이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency. (EPIC)

2026년 4월 23일 업데이트: Aimmune Nestlé Health Science US R&D, LLC

A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants With Exocrine Pancreatic Insufficiency- EPIC

The purpose of this study is to measure the safety and explore the efficacy of 4 different doses of the new lipase NHS7108 in participants with EPI. In this study, all participants will take NHS7108 daily for 14 days and a matching dose of standard-of-care, pancrelipase (Zenpep®) for 14 days according to Treatment Sequence assignment. Both NHS7108 and Zenpep® are oral capsules that will be taken with each of the daily 3 meals and 2 snacks. Participants will interrupt all of their usual pancrelipase/pancreatin treatment for up to 8 days during screening and for the entire 2 treatment periods, where participants will take either the new lipase NHS7108 or a matching dose of the standard-of-care pancrelipase (Zenpep®). Participants will be asked to stay in a setting that allows controlled diet and 72-hour stool collection for approximately 7 days during the screening period and again for approximately 7 days at the end of each treatment period. During these 3 supervised periods, participants will receive a standardized diet with a predefined amount of fat and protein, stools will be collected in special containers and during the last day of the treatment period, blood samples will be obtained to measure fat absorption. These are essential to ensure valid assessment of participants' fat and protein absorption. Outside the 3 supervised periods, participants will be provided with guidelines and recommendations to create their own home-controlled meals and snacks according to their preferences for the remainder of the study duration.

Number of Participants:

The aim is to have 56 participants completing the study. Assuming approximately 14% drop-out rate, approximately 66 participants will be randomized to study intervention.

Study Arms and Duration:

The total study duration for each participant will be about 100 days (approximately 14 weeks), including:

  • A screening period of up to approximately 28 days (might be extended up to a total of 56 days) prior to the first dose administration.
  • A crossover treatment period (2 treatment periods: approximately 14 days each, with no washout in between). For each treatment period, study intervention will be administered 5 times a day (with 3 main meals and 2 snacks). After completion of Treatment Period 1, the participant will receive and start the new treatment for Treatment Period 2.
  • An end of treatment/early discontinuation visit within approximately 7 days of the last study intervention dose.
  • An end-of-study safety follow-up visit at 14 (±2) days after the last dose administration.

Very low dose group: 10 mg NHS7108 (approximately 25,000 LU)/main meal and snack; 25,000 LU Zenpep/main meal and snack (50 mg NHS7108 [approximately 125,000 LU] per day; 125,000 LU Zenpep per day)

Low dose group: 20 mg NHS7108 (approximately 50,000 LU)/main meal and 10 mg NHS7108 (approximately 25,000 LU)/snack; 50,000 LU Zenpep/main meal and 25,000 LU Zenpep/snack (80 mg NHS7108 [approximately 200,000 LU] per day; 200,000 LU Zenpep per day)

Medium dose group: 40 mg NHS7108 (approximately 100,000 LU)/main meal and 20 mg (approximately 50,000 LU) NHS7108/snack; 100,000 LU Zenpep/main meal and 50,000 LU Zenpep/snack (160 mg [approximately 400,000 LU] NHS7108 per day; 400,000 LU Zenpep per day)

High dose group: 60 mg NHS7108 (approximately 150,000 LU)/main meal and 30 mg NHS7108 (approximately 75,000 LU)/snack; 150,000 LU Zenpep/main meal and 75,000 LU Zenpep/snack (240 mg NHS7108 [approximately 600,000 LU] per day; 600,000 LU Zenpep per day).

The dose for participants < 60 kg who are assigned to the high dose group will need to be weight-adjusted to ensure that they receive no more than 10,000 LU/kg/day.

연구 개요

상태

상태

현재 모집 상태 또는 확장 액세스 상태를 나타냅니다.
아직 모집하지 않음

정황

정황

연구 중인 질병, 장애, 증후군, 질환 또는 부상입니다. ClinicalTrials.gov에서 조건에는 수명, 삶의 질 및 건강 위험과 같은 기타 건강 관련 문제도 포함될 수 있습니다.

개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.

연구 유형

연구 유형

임상 연구의 특성을 설명합니다. 연구 유형에는 중재 연구(임상 시험이라고도 함), 관찰 연구(환자 등록 포함) 및 확장된 액세스가 포함됩니다.
중재적

등록 (추정된)

등록

임상 연구의 참가자 수. "예상" 등록은 연구원이 연구에 필요한 참가자의 목표 수입니다.
66

단계

단계

미국 식품의약국(FDA)에서 개발한 정의에 따라 약물 또는 생물학적 제품을 연구하는 임상 시험 단계입니다. 이 단계는 연구의 목적, 참가자 수 및 기타 특성을 기반으로 합니다. 초기 1단계(이전에는 0단계로 나열됨), 1단계, 2단계, 3단계 및 4단계의 5단계가 있습니다. 해당 없음은 장치 또는 행동 개입의 시험을 포함하여 FDA에서 정의한 단계가 없는 시험을 설명하는 데 사용됩니다.
  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처

임상 연구를 위한 등록 질문에 답변할 수 있는 사람의 이름과 연락처 정보. 연구가 수행되는 각 위치에는 이러한 질문에 더 잘 대답할 수 있는 특정 연락처가 있을 수 있습니다.

연구 장소

  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85258
        • HonorHealth Research Institute
        • 연락하다:
    • California
      • Los Angeles, California, 미국, 90033
        • Keck Hospital of USC
        • 연락하다:
      • Los Angeles, California, 미국, 90033
        • University of Southern California University Hospital (USCUH) - Internal Medicine
        • 연락하다:
    • Florida
    • Kansas
      • Lenexa, Kansas, 미국, 66219
        • Johnson County Clin-Trials (JCCT)
        • 연락하다:
    • Maine
      • Portland, Maine, 미국, 04102
        • Maine Medical Center - Division of Pulmonary and Critical Care Medicine
        • 연락하다:
    • Maryland
      • Baltimore, Maryland, 미국, 21205
        • Johns Hopkins Medicine - Pulmonary and Critical Care
        • 연락하다:
    • Ohio
      • Cleveland, Ohio, 미국, 44106
        • University Hospitals Cleveland Medical Center/Rainbow Babies & Children's Hospital
        • 연락하다:
      • Columbus, Ohio, 미국, 43210
        • The Ohio State University College of Medicine (OSUCOM)
        • 연락하다:
  • 불가리아
      • Lovech, 불가리아, 5500
        • Medical Center Medconsult Pleven, Lovech branch
        • 연락하다:
      • Pleven, 불가리아, 5800
      • Plovdiv, 불가리아, 4000
        • MC Hipokrat-N - Gastroenterology
        • 연락하다:
      • Sofia, 불가리아, 1463
  • 스페인
      • Lleida, 스페인, 25198
        • Hospital Universitari Arnau de Vilanova de Lleida
        • 연락하다:
      • Málaga, 스페인, 29010
        • H. General de Málaga - Endocrinología
      • Valencia, 스페인, 46026
        • Hospital Universitario y Politecnico La Fe - Neumología
        • 연락하다:
          • Amparo Solé Jover
          • 전화번호: 3496-386-27-00
          • 이메일: sole_amp@gva.es
    • Barcelona
      • Madrid, Barcelona, 스페인, 46026
        • Hospital Clinic De Barcelona - Cirug-ía General y Digestiva
        • 연락하다:
  • 영국
      • Glasgow, 영국, G12 0XH
      • Newcastle upon Tyne, 영국, NE1 4LP
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary
        • 연락하다:
    • Merseyside
      • Liverpool, Merseyside, 영국, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
        • 연락하다:
  • 이탈리아
      • Florence, 이탈리아, 50134
        • Azienda Ospedaliero Universitaria Careggi - Gastroenterologia
        • 연락하다:
      • Milan, 이탈리아, 20132
        • IRCCS Ospedale San Raffaele - Endoscopia Biliopancreatica
        • 연락하다:
      • Roma, 이탈리아, 00189
        • Azienda Ospedaliera Universitaria Sant'Andrea
        • 연락하다:
    • Lombardy
      • Rozzano, Lombardy, 이탈리아, 20089
  • 폴란드
      • Śląskie, 폴란드, 43-100
        • H-T. Centrum Medyczne-Endoterapia
        • 연락하다:
    • Warszawa
      • Pomorskie, Warszawa, 폴란드, 04-501
        • WIP Warsaw IBD Point Profesor Kierkus
        • 연락하다:
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, 폴란드, 93-357
        • Bonifraterskie Centrum Medyczne Sp. z o.o. Oddzial w Lodzi, Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi - Dzial Endoskopi
        • 연락하다:
          • Wojciech Piotrowski
          • 전화번호: 48501658212
          • 이메일: wojtekp4@wp.pl
  • 헝가리
      • Budapest, 헝가리, 1062
        • MH Egészségügyi Központ - Gasztroenterológiai Osztály
        • 연락하다:
      • Budapest, 헝가리, 1082
        • Semmelweis Egyetem. Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika - Gasztroenterologiai Osztaly
        • 연락하다:
      • Csongrád, 헝가리, 6720
        • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

자격 기준

임상 연구에 참여하고자 하는 사람들이 충족해야 하는 주요 요구 사항 또는 그들이 가져야 할 특성. 자격 기준은 포함 기준(사람이 연구에 참여하는 데 필요함)과 제외 기준(사람이 참여하지 못하게 하는 것)으로 구성됩니다. 적격성 기준 유형에는 연구가 건강한 지원자를 받아들이는지, 연령 또는 연령 그룹 요구 사항이 있는지 또는 성별에 따라 제한되는지가 포함됩니다.

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Participant is a male or female between 18 to 85 years of age, inclusive, at the time of signing the informed consent.
  2. Participants with clinically confirmed* chronic established (not due to a transient clinical diagnosis, i.e., acute pancreatitis) EPI and with a clinical indication for PERT.
  3. CFA off PERT of <80% at screening
  4. Normal body mass index (BMI) by age and sex to ensure participant's EPI is adequately controlled in the opinion of the investigator (BMI of at least 17.0 and no greater than 35.0 kg/m²)
  5. Standard-of-care medications are allowed (antibiotics, mucolytic agents, aerosols, antacids), if on stable doses for at least 1 month prior to baseline CFA and CNA assessments and must not be altered in dose or stopped during the study.
  6. Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators are allowed if on stable doses for at least 3 months prior to randomization. Participants should not start taking CFTR modulators during the duration of the study.

  7. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    Male Participants:

    • Non-sterilized male participants are eligible to participate if they agree to one of the following starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up: Must agree to stay abstinent (where abstinence is the preferred and usual lifestyle of the participant), OR male participants with a female partner of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method). Male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration. These requirements also apply to participants in a same sex relationship.
    • Male participants must agree not to donate sperm starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up.

    Female Participants:

    • Female participants of childbearing potential (as defined in Appendix 4) are eligible to participate if they meet the following criteria: Agree not to become pregnant during the clinical study period and until the end-of-study safety follow-up. Have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1. If heterosexually active, must agree to consistently use a form of highly effective birth control, in combination with a barrier method starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up, OR agree to stay abstinent (where abstinence is the preferred and usual lifestyle of the participant), starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up. These requirements do not apply to participants in a same sex relationship.
    • Female participants of nonchildbearing potential are eligible to participate if one of the following conditions apply: Must have a confirmed clinical history of sterility (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the participant's medical records, medical examination, or medical history interview). Must be postmenopausal as defined as: amenorrhea for at least 1 year prior to screening and a laboratory confirmed serum follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL. Female participants on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the non-estrogen hormonal highly effective contraception methods from screening until at and continuing throughout the clinical study period, and until the end-of-study safety follow-up if they wish to continue their HRT during the study.
    • Female participants must agree not to donate ova starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up.
    • For WOCBP only, serum pregnancy test will be performed at screening and urine pregnancy tests will be performed at the timepoints outlined in the SoA.
    • The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  8. Participants are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  9. Participants agree not to participate in another interventional study while participating in the study.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  1. Female participants who are breastfeeding at the time of screening.
  2. Previous GI surgery, except for non-invasive neonatal or early childhood procedures such as correction of hypertrophic pyloric stenosis, surgical correction of Meckel's diverticulum, volvulus, or intestinal intussusception. Hernia repair, appendectomy, cesarean section, tubal ligation, hysterectomy, polypectomy, hemorrhoidectomy, or cholecystectomy are allowed if performed at least 2 years before randomization and have no impact on intestinal transit or absorption.
  3. Participants on enteral feeding.
  4. Participants with celiac disease.
  5. Known allergy or adverse reaction history to any component of NHS7108, Zenpep®, omega-3 oil, and/or to any other product administered during the study, including the blue dye.
  6. Concurrent clinically significant, at the discretion of the Investigator, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, and seasonal allergies and childhood asthma) or any other disorder that in the opinion of the Investigator may put the participant at greater safety risk, influence response to study intervention, or interfere with study assessments.
  7. Concurrent conditions having a clinically significant impact on GI motility function, with the exception of pancreatic insufficiency due to pancreatectomy or CP.
  8. Any significant clinical/laboratory/radiological sign of unstable or unexpectedly deteriorating respiratory disease during the study duration, at the discretion of the Investigator.
  9. Omega-3 supplements are prohibited during all the study periods and should be stopped at least 7 days prior to the baseline off-treatment fat absorption assessments.
  10. Participants starting new medications or changing dose within 1 month before baseline off-treatment screening assessments.
  11. Acute use of oral or intravenous antibiotics within 2 weeks prior to the first dose of study intervention.
  12. Treatment with any investigational drug or device/treatment within the 30 days or 5 half-lives of the drug (whichever is longer) prior to first dose of study intervention.

  13. Participant has any clinically significant abnormalities in hematology, coagulation, clinical chemistry, or urinalysis at screening as judged by the Investigator OR as detailed below:

    • Estimated glomerular filtration rate < 60 mL/min at screening visit.
    • Total bilirubin > 1.5 × upper limit of normal (ULN) at screening visit.
    • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × ULN at screening visit.
  14. Positive human immunodeficiency virus (HIV) antibody test.
  15. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
  16. Positive hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to first dose of study intervention AND positive on reflex to hepatitis C RNA test.
  17. Concurrent drug or alcohol addiction that in the opinion of the Investigator would preclude participation and compliance with the study procedures.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔

참가자 그룹 / 팔

시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.
개입 / 치료

개입 / 치료

임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
다른: Very Low Dose Group
10 mg NHS7108 [approximately 25,000 LU]/main meal and snack; 25,000 LU Zenpep/main meal and snack.
의약품: NHS7108

NHS7108 is the experimental drug. It is a recombinant, modified version of a triacylglycerol lipase enzyme derived from the bacteria Bacillus thermoamylovorans and produced by fermentation of recombinant Escherichia coli.

Unit dose strength: 10 mg (approximately 25,000 LU) per capsule.

의약품: Zenpep®
Zenpep® is the active comparator. It is a combination of lipases, proteases, and amylases. Unit dose strength: 25,000 LU per capsule.
다른: Low Dose Group
20 mg NHS7108 [approximately 50,000 LU]/main meal and 10 mg NHS7108 [approximately 25,000 LU]/snack; 50,000 LU Zenpep/main meal and 25,000 LU Zenpep/snack.
의약품: NHS7108

NHS7108 is the experimental drug. It is a recombinant, modified version of a triacylglycerol lipase enzyme derived from the bacteria Bacillus thermoamylovorans and produced by fermentation of recombinant Escherichia coli.

Unit dose strength: 10 mg (approximately 25,000 LU) per capsule.

의약품: Zenpep®
Zenpep® is the active comparator. It is a combination of lipases, proteases, and amylases. Unit dose strength: 25,000 LU per capsule.
다른: Medium Dose Group
40 mg NHS7108 [approximately 100,000 LU]/main meal and 20 mg NHS7108 [approximately 50,000 LU]/snack; 100,000 LU Zenpep/main meal and 50,000 LU Zenpep/snack.
의약품: NHS7108

NHS7108 is the experimental drug. It is a recombinant, modified version of a triacylglycerol lipase enzyme derived from the bacteria Bacillus thermoamylovorans and produced by fermentation of recombinant Escherichia coli.

Unit dose strength: 10 mg (approximately 25,000 LU) per capsule.

의약품: Zenpep®
Zenpep® is the active comparator. It is a combination of lipases, proteases, and amylases. Unit dose strength: 25,000 LU per capsule.
다른: High Dose Group
60 mg NHS7108 [approximately 150,000 LU]/main meal and 30 mg NHS7108 [approximately 75,000 LU]/snack; 150,000 LU Zenpep/main meal and 75,000 LU Zenpep/snack.
의약품: NHS7108

NHS7108 is the experimental drug. It is a recombinant, modified version of a triacylglycerol lipase enzyme derived from the bacteria Bacillus thermoamylovorans and produced by fermentation of recombinant Escherichia coli.

Unit dose strength: 10 mg (approximately 25,000 LU) per capsule.

의약품: Zenpep®
Zenpep® is the active comparator. It is a combination of lipases, proteases, and amylases. Unit dose strength: 25,000 LU per capsule.

연구는 무엇을 측정합니까?

주요 결과 측정

주요 결과 측정

임상 연구 프로토콜에서 개입/치료의 효과를 평가하는 데 가장 중요한 계획된 결과 측정. 대부분의 임상 연구에는 하나의 주요 결과 측정이 있지만 일부는 둘 이상입니다.
결과 측정
측정값 설명
기간
Primary Objectives: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14 days after NHS7108 Treatment

Endpoint: Number of participants reporting 1 or more adverse events.

Events Meeting the AE Definition:

  • Any abnormal laboratory test results or other safety assessments including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
  • Exacerbation of a chronic or in or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition.
  • New condition detected or diagnosed after study intervention administration even though it may have been present before the start of the study.
  • Signs, symptoms, or the clinical sequelae of a suspected intervention-intervention interaction.
  • Signs, symptoms, or the clinical sequelae of a suspected overdose of either study intervention or a concomitant medication.
14 days after NHS7108 Treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: At screening and end-of-study/safety follow-up visit. A brief symptom-directed physical examination may be performed at all other visits and at any time throughout the study, as clinically indicated.
A complete physical examination will be performed and include, at a minimum, assessments of general appearance, head, ears, eyes, nose, throat, neck (including thyroid), skin, cardiovascular system, respiratory system, GI system, musculoskeletal system, lymph nodes, and nervous system.
At screening and end-of-study/safety follow-up visit. A brief symptom-directed physical examination may be performed at all other visits and at any time throughout the study, as clinically indicated.
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include vital sign measurement, which will include Blood Pressure.

Units of measurement for Blood Pressure: Millimeters of mercury (mm Hg)
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include vital sign measurement, which will include Heart Rate.

Units of measurement for Heart Rate: Beats Per Minute (BPM)
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include vital sign measurement, which will include respiratory rate measurement.

Units of measurement for respiratory rate measurement: breaths per minute (bpm).
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment.

Endpoint: Changes from baseline in safety parameters include vital sign measurement, which will include body temperature.

Units of measurement for body temperature: degrees Celsius (°C).
After 14 -day NHS7108 treatment.
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment
Endpoint: Changes from baseline in safety parameters include 12-Lead electrocardiogram (ECG) recording. 12-lead ECG will be recorded as single bedside measurements using an ECG machine that automatically calculates the heart rate and measures: 1. PR interval (millisecond (ms)).
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment
Endpoint: Changes from baseline in safety parameters include 12-Lead electrocardiogram (ECG) recording. 12-lead ECG will be recorded as single bedside measurements using an ECG machine that automatically calculates the heart rate and measures: 2. QRS, and QT (QT interval corrected for heart rate using Fridericia's correction [QTcF]) intervals.
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14-day after NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology tests:

  1. Platelet count (x10E3/uL)
  2. White Blood Cell count with differential (percent and absolute): Neutrophils (x10E3/uL)
14-day after NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14-day after NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:

3. RBC count (x10E6/uL)
14-day after NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14-day after NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:

4. Hemoglobin (g/dl) 5. Mean cell hemoglobin concentration (g/dl)
14-day after NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14-day after NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:

6. RBC indices: Mean Corpuscular Volume (femtoliters (fL)).
14-day after NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14-day after NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:

7. Mean Corpuscular Hemoglobin (picograms (pg)).
14-day after NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14-day after NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:

8. Hematocrit (%), 9. Reticulocytes (%), 10. WBC count with differential (percent and absolute): Lymphocytes (%), Monocytes (%), Eosinophils(%), Basophils (%).
14-day after NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14-day after NHS7108 treatment
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Coagulation: 1. Fibrinogen (mg/dL), Prothrombin time (Sec) , Activated partial thromboplastin time (Sec).
14-day after NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: 14 -day after NHS7108 treatment
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Coagulation: 2. Prothrombin time (Sec) , 3. Activated partial thromboplastin time (Sec).
14 -day after NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 1. Bicarbonate (mmol/L), 2. Sodium(mmol/L), 3. Potassium (mmol/L), 4. Chloride (mmol/L).
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 5. Albumin (g/dL), 6. Total protein (g/dL).
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 7. Blood glucose (fasting at screening only) (mg/dL), 8. Phosphate (mg/dL), 9. Calcium (mg/dL), 10. Urea (mg/dL), 11. Creatinine (mg/dL), 12. Uric acid/urate (mg/dL), 13. Total and direct bilirubin (mg/dL), 14. Triglycerides (mg/dL), 15. Total Cholesterol (mg/dL).
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 16. Creatine kinase (U/L), 17. AST/SGOT (U/L), 18. ALT/SGPT (U/L), 19. Alkaline phosphatase 2 (U/L), 20. GGT (U/L), 21. Lactate dehydrogenase (U/L).
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: After 14 -day NHS7108 treatment

Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Routine Urinalysis: Leukocyte esterase, Protein, Urobilinogen, Ketones, Bilirubin, Microscopic examination (if blood, leukocytes, or protein is abnormal), Blood, pH, Nitrite, Specific gravity, Glucose.

All the above urinalysis are reported in absolute units. They are semi-quantitative. Hence no units of measurement.
After 14 -day NHS7108 treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: Serum Beta-HCG pregnancy test (mIU/mL) (at screening) and urine pregnancy tests (at all other timepoints) as needed for women of childbearing potential.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Pregnancy Testing. Highly sensitive serum Beta-HCG pregnancy test (mIU/mL) and urine pregnancy tests (no units)
Serum Beta-HCG pregnancy test (mIU/mL) (at screening) and urine pregnancy tests (at all other timepoints) as needed for women of childbearing potential.
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety.
기간: Will be performed at screening in women with unconfirmed reproductive potential status only (to confirm postmenopausal state).
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Other Screening Tests: 1. Follicle Stimulating Hormone- FSH (IU/L).
Will be performed at screening in women with unconfirmed reproductive potential status only (to confirm postmenopausal state).
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety
기간: 14 days after NHS7108 Treatment
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Other Screening Tests: 2. Serology: HIV antibody, hepatitis B surface antigen, and hepatitis C virus antibody, hepatitis B surface antibody and hepatitis B core antibody total. (No units)
14 days after NHS7108 Treatment
Primary Objective: Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety
기간: After 14 days NHS7108 treatment
Endpoint: Change from baseline in the Coefficient of Nitrogen Absorption (CNA).CNA expresses the ratio between the amount of nitrogen absorbed and the amount of nitrogen provided with the diet. It will also be analyzed from the stool collection period. CNA is calculated as follows: nitrogen intake (g) - excreted nitrogen (g)/nitrogen intake (g), expressed as percentage (%).
After 14 days NHS7108 treatment

기타 결과 측정

기타 결과 측정

임상 시험의 경우 참가자에 대한 개입/치료의 효과를 결정하는 데 사용되는 프로토콜에 설명된 계획된 측정입니다. 관찰 연구에서 질병이나 특성의 패턴 또는 노출, 위험 요인 또는 치료와의 연관성을 설명하는 데 사용되는 측정 또는 관찰입니다. 결과 측정 유형에는 1차 결과 측정과 2차 결과 측정이 포함됩니다.
결과 측정
측정값 설명
기간
Exploratory Objective: A) The effect of different doses of NHS7108 administered for 14 days in participants with EPI on fat absorption
기간: After 14 day NHS7108 treatment
Endpoint: 1. Change from baseline in the CFA. CFA expresses the ratio between the amount of fat absorbed and the amount of fat provided with the diet and is considered the gold standard for the evaluation of efficacy of PERT. It requires collection of stools produced over a 72-hour period within a timeframe of approximately 7 days at the end of each treatment period, while the participant consumes a controlled diet providing a predefined amount of fat.
After 14 day NHS7108 treatment
Exploratory Objective: A) The effect of different doses of NHS7108 administered for 14 days in participants with EPI on fat absorption
기간: 14 days after NHS7108 treatment
2. Omega-3 absorption test: change from baseline in post-prandial EPA and DHA content of plasma over a 24-hour period after standard breakfast along with area under the plasma level of EPA- and DHA-time curve from 0 (before breakfast) to 24 hours post-prandial (AUC0-24) and maximum plasma level of EPA and DHA (Cmax).
14 days after NHS7108 treatment
Exploratory objective: B) Effects of NHS7108 on gastrointestinal (GI) symptoms
기간: after 14-day NHS7108 treatment
Endpoint: 1.Change from baseline in the Gastrointestinal Symptom Rating Scale (included in the eDiary)
after 14-day NHS7108 treatment
Exploratory objective: B) Effects of NHS7108 on gastrointestinal (GI) symptoms
기간: After 14-day NHS7108 treatment
Endpoint: 2. Stool frequency as assessed by the eDiary
After 14-day NHS7108 treatment
Exploratory objective: B) Effects of NHS7108 on gastrointestinal (GI) symptoms
기간: After 14-day NHS7108 treatment
Endpoint: 3. Stool consistency as assessed by the Scale named: Bristol Stool Scale (included in the eDiary)
After 14-day NHS7108 treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

스폰서

연구를 시작하고 연구에 대한 권한과 통제권을 가진 조직 또는 사람.
Aimmune Nestlé Health Science US R&D, LLC

협력자

협력자

임상 연구를 지원하는 스폰서 이외의 조직. 이 지원에는 자금 조달, 설계, 구현, 데이터 분석 또는 보고와 관련된 활동이 포함될 수 있습니다.
Parexel

수사관

수사관

임상 연구에 참여하는 연구원. 관련 용어에는 사이트 주임 조사관, 사이트 하위 조사자, 연구 의자, 연구 책임자 및 연구 주임 조사관이 포함됩니다.
  • 연구 책임자: Monique Bunyan, Aimmune Nestlé Health Science US R&D, LLC (Role: Associate Clinical Project Manager)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

연구 시작

첫 번째 참가자가 임상 연구에 등록된 실제 날짜입니다. "예상" 연구 시작 날짜는 연구자가 연구 시작 날짜가 될 것이라고 생각하는 날짜입니다.
2026년 4월 1일

기본 완료 (추정된)

기본 완료

임상 연구의 마지막 참가자가 1차 결과 측정을 위한 최종 데이터를 수집하기 위해 검사를 받거나 개입을 받은 날짜입니다. 임상 연구가 프로토콜에 따라 종료되었는지 또는 종료되었는지 여부는 이 날짜에 영향을 미치지 않습니다. 완료 날짜가 다른 1차 결과 측정이 둘 이상인 임상 연구의 경우 이 용어는 모든 1차 결과 측정에 대한 데이터 수집이 완료된 날짜를 나타냅니다. "예상" 기본 완료 날짜는 연구원이 연구의 기본 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2027년 6월 1일

연구 완료 (추정된)

연구 완료

임상 연구의 마지막 참가자가 1차 결과 측정, 2차 결과 측정 및 부작용(즉, 마지막 참가자의 마지막 방문)에 대한 최종 데이터를 수집하기 위해 검사를 받거나 중재/치료를 받은 날짜입니다. "예상" 연구 완료 날짜는 연구원이 연구 완료 날짜가 될 것이라고 생각하는 날짜입니다.
2027년 9월 1일

연구 등록 날짜

최초 제출

최초 제출

연구 후원자 또는 연구자가 최초로 ClinicalTrials.gov에 연구 기록을 제출한 날짜. 일반적으로 처음 제출한 날짜와 ClinicalTrials.gov에서 기록을 사용할 수 있는 날짜(첫 게시 날짜) 사이에는 며칠의 지연이 있습니다.
2026년 3월 26일

QC 기준을 충족하는 최초 제출

QC 기준을 충족하는 최초 제출

연구 스폰서 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록을 처음 제출한 날짜입니다. 의뢰자 또는 조사자는 NLM의 QC 검토 기준이 충족되기 전에 연구 기록을 한 번 이상 수정하고 제출해야 할 수 있습니다. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2026년 4월 23일

처음 게시됨 (실제)

처음 게시됨

National Library of Medicine(NLM) 품질 관리(QC) 검토가 완료된 후 ClinicalTrials.gov에서 연구 기록을 처음 사용할 수 있는 날짜입니다. 일반적으로 연구 후원자 또는 연구자가 연구 기록을 제출한 날짜와 처음 게시된 날짜 사이에는 며칠의 지연이 있습니다.
2026년 4월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

마지막 업데이트 게시됨

ClinicalTrials.gov에서 연구 기록이 변경된 가장 최근 날짜. 연구 후원자 또는 연구자가 변경 사항을 ClinicalTrials.gov에 제출한 시점(마지막 업데이트 제출 날짜)과 마지막 업데이트 게시 날짜 사이에 지연이 있을 수 있습니다.
2026년 4월 30일

QC 기준을 충족하는 마지막 업데이트 제출

QC 기준을 충족하는 마지막 업데이트 제출

연구 후원자 또는 연구자가 국립 의학 도서관(NLM) 품질 관리(QC) 검토 기준과 일치하는 연구 기록에 대한 변경 사항을 제출한 가장 최근 날짜. 연구 기록이 NLM QC 검토 기준과 일치하는지 확인하는 것은 후원자 또는 조사자의 책임입니다.
2026년 4월 23일

마지막으로 확인됨

마지막으로 확인됨

연구 후원자 또는 조사자가 ClinicalTrials.gov에서 임상 연구에 대한 정보가 정확하고 최신 정보라고 확인한 가장 최근 날짜. 모집 상태가 모집인 연구인 경우; 아직 모집하지 않았습니다. 또는 활성, 비모집이 지난 2년 이내에 확인되지 않은 경우 연구의 모집 상태는 알 수 없음으로 표시됩니다.
2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

기타 연구 ID 번호

연구 후원자, 기금 제공자 또는 다른 사람이 임상 연구에 할당한 NCT 번호 이외의 식별자 또는 ID 번호. 이 번호에는 다른 시험 등록의 고유 식별자와 미국 국립보건원(National Institutes of Health) 보조금 번호가 포함될 수 있습니다.
  • 2307CLI

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

쿠키 설정

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