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

A Phase 1 Study of SSS17 in Healthy Subjects.

2021년 12월 27일 업데이트: Shenyang Sunshine Pharmaceutical Co., LTD.

A Phase 1 Study to Evaluate the Tolerance, Safety, Pharmacokinetics and Pharmacodynamics of Oral Administration of SSS17 in Chinese Healthy Adult Subjects With Single and Multiple Dose Escalation and the Effect of Food on the Pharmacokinetics of SSS17.

This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance, pharmacokinetics and pharmacodynamics of multiple oral administration of 15 mg and 20 mg of SSS17 compared with placebo. In addition, the study will assess the effect of food on the pharmacokinetics of SSS17.

연구 개요

상세 설명

The study will enroll healthy volunteers from a single academic medical center in China. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.The study will be divided into 3 parts.

Part 1: Subjects will be allocated 2:8 to receive placebo or SSS17(it was only 2:2 in 5mg dose group),which will be administered by oral route with single dose. At each dose, tolerability, safety, PK and PD characteristics will be investigated.

Part 2: Subjects will be allocated 2:8 to receive placebo or SSS17, which will be administered by oral route with multiple dose. At each cohort,tolerability, safety, PK and PD characteristics will be investigated.

Part 3: The subjects will receive two cycles of treatment, one is given on an empty stomach, the other is given after a high-fat meal, with an interval of 15 days.

연구 유형

중재적

등록 (예상)

76

단계

  • 1단계

연락처 및 위치

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

연구 연락처

연구 연락처 백업

  • 이름: Professor Fang, Ph.D
  • 전화번호: 13701165926
  • 이메일: fygk7000@163.com

연구 장소

    • Guangdong
      • Guangzhou, Guangdong, 중국, 510700
        • 모병
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • 연락하다:
        • 연락하다:

참여기준

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

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Chinese healthy adult subjects aged 18-45 years (including the boundary value) at the time of signing the informed consent were male and female;
  • In the screening period, the weight of male subjects was more than or equal to 50.0 kg; Female weight ≥ 45.0 kg; Body mass index (BMI) ranged from 19.0 kg / m2 to 26.0 kg / m2 (including boundary value); BMI = weight kg / height m2);
  • Within 6 months from the date of signing the informed consent to the end of the trial, female subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan, while male subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan;
  • Willing to participate in the study and sign a written informed consent, able to communicate well with the researchers, and agreed to follow the requirements of the trial protocol and follow-up on schedule.

Exclusion Criteria:

  • Participated in other drug clinical trials within 3 months before screening;
  • Have any clinical history of serious diseases or are suffering from related diseases, including but not limited to digestive system (such as diarrhea, vomiting, inflammatory bowel disease, hemorrhoids, acute gastritis, peptic ulcer, acute and chronic gastrointestinal disorders with obvious digestive and absorption disorders), cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, gastrointestinal tract diseases, etc Diseases of nervous and mental system, blood system, immune system, etc; A history of any disease or thrombotic disease or vascular malformation that increases the risk of bleeding; Patients with dysphagia;
  • Allergic constitution, known allergic to test drug ingredients or allergic history to any drug or food (mango, shrimp, crab, lobster, etc.) or pollen allergy history;
  • Those who smoke more than 5 cigarettes / day or the same amount of tobacco after inquiry, or who can not ban smoking during the trial period; Or alcohol consumption per week is equal to 14 units (1 units 25mL wine Baijiu / 100mL wine / 285mL beer), or those who can not prohibit alcohol during the test period;
  • Have a history of drug abuse or drug abuse;
  • Within 6 months, there were fertility planning, sperm donation and egg donation planning;
  • Patients with lactose intolerance (those who have had diarrhea after drinking milk);
  • Those who have special requirements for diet and cannot accept unified diet;
  • Blood donors or massive blood loss (≥ 400ml), EPO treatment, blood transfusion or use of blood products within 3 months before screening;
  • Those vaccinated within 8 weeks before screening or during the study period;
  • There was a history of acupuncture and blood sickness; Or with orthostatic hypotension;
  • Those who have participated in and used the trial drug;Those who have used any prescription drug, over-the-counter drug, Chinese herbal medicine, vitamins or health care products within 14 days before screening and whose time is less than 5 half-life of the drug or less than 2 weeks (whichever is the longest);
  • The serum pregnancy test of lactating and pregnant women, or female volunteers of childbearing age was positive;
  • The results of physical examination, chest X-ray, color Doppler ultrasound, electrocardiogram and laboratory examination were abnormal and clinically significant; Or hemoglobin of male subjects was more than 175.0 g / L; Or hemoglobin of female subjects was more than 150.0 g / L; Or hemoglobin of male and female were less than 113g / L;
  • Within 48 hours before enrollment, those who took any special diet that affected the absorption, distribution, metabolism and excretion of drugs, including pitaya, mango, grapefruit, lime, carambola or food or drink prepared from them, chocolate, and any food or drink containing caffeine;
  • Urine drug screening test was positive;
  • Alcohol breath test was positive within 24 hours before administration;
  • The researchers think that there are other cases that are not suitable for the trial.

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: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Part 1: Single Dose Escalation SSS17
Escalating doses of SSS17, single dose administration
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
위약 비교기: Part 1: Single Dose Escalation matching Placebo
Escalating doses of matching placebo, single dose administration
일치하는 위약.
실험적: Part 2: Multiple Dose Escalation SSS17
Escalating doses of SSS17, multiple dose administration
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
위약 비교기: Part 2: Multiple Dose Escalation matching Placebo
Escalating doses of matching placebo, multiple dose administration
일치하는 위약.
실험적: Part 3: Treatment Sequence 1 (A to B)
The subjects in the first cycle received oral administration of SSS17 on an empty stomach, and subjects in the second cycle received oral administration of SSS17 after a high-fat meal
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
실험적: Part 3: Treatment Sequence 2 (B to A)
The subjects in the first cycle received oral administration of SSS17 after a high-fat meal, and the subjects in the second cycle received oral administration of SSS17 on an empty stomach
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part 1: AEs
기간: Baseline up to Days 15
Assessment AEs by frequency and severity in the part 1
Baseline up to Days 15
Part 1: Maximum plasma concentration (Cmax) of SSS17
기간: Up to 336 hours post-dose
Plasma samples will be collected and Cmax will be assessed in the part 1
Up to 336 hours post-dose
Part 1: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
기간: Up to 336 hours post-dose
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 1
Up to 336 hours post-dose
Part 1: Time-to-Cmax (Tmax) of SSS 17
기간: Up to 336 hours post-dose
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 1
Up to 336 hours post-dose
Part 1: Elimination terminal half-life (t1/2) of SSS17
기간: Up to 336 hours post-dose
Plasma samples will be collected and the t1/2 will be assessed in the part 1
Up to 336 hours post-dose
Part 1: . Total amount of SSS17 excreted in urine over 72 hours (Ae0-72)
기간: Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed in the part 1
Up to 72 hours post-dose
Part 1: Fraction of SSS17 excretion during each collection interval (Fe0-72)
기간: Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed in the part 1
Up to 72 hours post-dose
Part 1: Renal clearance (CLR) of SSS17
기간: Up to 72 hours post-dose
Urine sample will be collected at pre-specified intervals and CLR will be assessed in the part 1
Up to 72 hours post-dose
Part 2: AEs
기간: Up to Days 33 or 57
Assessment AEs by frequency and severity in the part 2
Up to Days 33 or 57
Part 2: Steady state minimal concentration (Css_min) of SSS17
기간: Up to Days 33 or 57
Plasma samples will be collected and Css_min will be assessed in the part 2
Up to Days 33 or 57
Part 2: Steady state maximum concentration (Css_max) of SSS17
기간: Up to Days 33 or 57
Plasma samples will be collected and Css_max will be assessed in the part 2
Up to Days 33 or 57
Part 2: Steady state average concentration (Css_av) of SSS17
기간: Up to Days 33 or 57
Plasma samples will be collected and Css_av will be assessed in the part 2
Up to Days 33 or 57
Part 2: Area under the concentration-time curve of plasma concentration of SSS17 within the interval of administration after reaching steady state (AUC0-τ)
기간: Up to Days 33 or 57
Plasma samples will be collected and the AUC from zero to τ will be assessed
Up to Days 33 or 57
Part 3: Maximum plasma concentration (Cmax) of SSS17
기간: Up to Days 44
Plasma samples will be collected and Cmax will be assessed in the part 3
Up to Days 44
Part 3: Area under the concentration-time curve (AUC) of plasma concentration of SSS17
기간: Up to Days 44
Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 3
Up to Days 44
Part 3: Time-to-Cmax (Tmax) of SSS 17
기간: Up to Days 44
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 3
Up to Days 44
Part 3: Elimination terminal half-life (t1/2) of SSS17
기간: Up to Days 44
Plasma samples will be collected and the t1/2 will be assessed in the part 3
Up to Days 44

2차 결과 측정

결과 측정
측정값 설명
기간
Part 1: EPO concentrations
기간: Up to 168 hours post-dose
Change of EPO concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: VEGF concentrations
기간: Up to 168 hours post-dose
Change of VEGF concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: Change of hepcidin from baseline
기간: Up to 168 hours post-dose
Change of serum hepcidin concentrations from baseline following SSS17 in the part 1
Up to 168 hours post-dose
Part 1: Change of RTC from baseline
기간: Baseline up to Days 15
Change of RTC from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 1: Change of RBC from baseline
기간: Baseline up to Days 15
Change of RBC from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 1: Change of Hgb from baseline
기간: Baseline up to Days 15
Change of Hgb from baseline following SSS17 in the part 1
Baseline up to Days 15
Part 2: EPO concentrations
기간: Up to Days 33 or 57
Change of EPO concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: VEGF concentrations
기간: Up to Days 33 or 57
Change of VEGF concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: Change of hepcidin from baseline
기간: Up to Days 33 or 57
Change of serum hepcidin concentrations from baseline following SSS17 in the part 2
Up to Days 33 or 57
Part 2: Change of RTC from baseline
기간: Baseline up to Days 33 or 57
Change of RTC from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 2: Change of RBC from baseline
기간: Baseline up to Days 33 or 57
Change of RBC from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 2: Change of Hgb from baseline
기간: Baseline up to Days 33 or 57
Change of Hgb from baseline following SSS17 in the part 2
Baseline up to Days 33 or 57
Part 3: AEs
기간: Up to Days 44
Assessment AEs by frequency and severity in the part 3
Up to Days 44
Part 3: EPO concentrations
기간: Up to Days 44
Change of EPO concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: VEGF concentrations
기간: Up to Days 44
Change of VEGF concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: Change of hepcidin from baseline
기간: Up to Days 44
Change of serum hepcidin concentrations from baseline following SSS17 in the part 3
Up to Days 44
Part 3: Change of RTC from baseline
기간: Baseline up to Days 44
Change of RTC from baseline following SSS17 in the part 3
Baseline up to Days 44
Part 3: Change of RBC from baseline
기간: Baseline up to Days 44
Change of RBC from baseline following SSS17 in the part 3
Baseline up to Days 44
Part 3: Change of Hgb from baseline
기간: Baseline up to Days 44
Change of Hgb from baseline following SSS17 in the part 3
Baseline up to Days 44

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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 (실제)

2021년 7월 26일

기본 완료 (예상)

2022년 12월 31일

연구 완료 (예상)

2023년 6월 30일

연구 등록 날짜

최초 제출

2021년 5월 17일

QC 기준을 충족하는 최초 제출

2021년 5월 17일

처음 게시됨 (실제)

2021년 5월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 1월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 12월 27일

마지막으로 확인됨

2021년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • SYSS-SSS17-UND-I-02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

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. .

구독하다