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

Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults

2026년 11월 9일 업데이트: Nanjing Immunophage Biotech Co., Ltd

A Phase Ⅰ Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Weight-Loss Effect of IPG1094 Tablets in Chinese Healthy Adults and Obese Adult Participants

This is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary weight-loss effect of IPG1094 tablets. The study includes three parts: Part A is single ascending dose in healthy volunteers; Part B is multiple ascending dose in healthy volunteers; Part C is multiple-dose exploration in obese adult participants. Subjects will be randomly assigned to receive IPG1094 or matching placebo. Safety, blood drug concentration and weight-related indicators will be followed up.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

72

단계

  • 1단계

연락처 및 위치

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

연구 연락처

연구 장소

    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310013
        • Zhejiang Hospital
        • 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

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Male and female Chinese participants aged 18-50 years inclusive.
  2. Part A/B (healthy adults): Physical examination, vital signs, 12-lead ECG, chest X-ray, laboratory tests are normal or abnormalities considered not clinically significant by investigator; male body weight ≥50.0 kg, female ≥45.0 kg; BMI 19.0-26.0 kg/m².
  3. Part C (obese adults): BMI 28.0-35.0 kg/m²; body weight stable within 3 months prior to screening (weight change ≤5%). No concomitant diseases interfering with safety, PK or weight evaluation.
  4. Female participants are non-pregnant and non-lactating.
  5. All participants (male and female) agree to use effective contraception from informed consent through 6 months after last study drug administration; no plan for pregnancy, sperm / oocyte donation.
  6. For Part C: Able to complete hospitalization for first 10 days, outpatient visits, home drug administration and study diary; refrain from additional weight-loss medications, bariatric surgery or intensive weight-loss programs.
  7. Voluntarily sign written informed consent form.

Exclusion Criteria:

  1. History of severe/uncontrolled cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological or psychiatric diseases with ongoing clinical significance.
  2. ECG: QTcF >450 ms (male) / >470 ms (female).
  3. Recurrent headache/migraine, recurrent nausea/vomiting.
  4. Blood donation ≥400 mL within 3 months before screening.
  5. History of orthostatic hypotension, dysphagia.
  6. Gastrointestinal disorders affecting drug absorption.
  7. Cannot comply with unified diet requirements, lactose intolerance.
  8. Major surgery within 3 months before screening or planned surgery during study.
  9. Known hypersensitivity to study drug or placebo excipients.
  10. Alcohol or substance abuse history; positive drug-of-abuse screen or positive alcohol breath test.
  11. Excessive alcohol / tobacco / caffeine intake defined per protocol.
  12. Use of metformin or other biguanides within 3 months before screening; systemic glucocorticoids within 1 month before screening; CYP-modifying drugs within 30 days before screening; prescription/OTC/herbal products within 14 days before screening.
  13. Consumption of grapefruit / citrus fruits/juice within 5 days pre-screening and refusal to abstain during study.
  14. Vaccines or biological agents within 4 months pre-screening or planned during study.
  15. Participation in another interventional clinical trial within 3 months before screening.
  16. Difficult venous access, history of needle-phobia.
  17. Acute disease within 14 days prior to screening.
  18. Other conditions judged inappropriate for enrollment by investigator. Additional Exclusion for Part C (obese participants): Fasting glucose ≥11.0 mmol/L or HbA1c ≥8.0%; secondary obesity, eating disorders, clinically significant cardiovascular disease, moderate-severe obstructive sleep apnea, active liver disease, significant renal impairment.

Repeated BP: SBP ≥160 mmHg or DBP ≥100 mmHg; ALT/AST >2×ULN; total bilirubin >1.5×ULN; eGFR <60 mL/min/1.73 m².

Weight-loss drugs, intensive weight-loss program within 3-month pre-screening; prior or planned bariatric surgery.

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: 순차적 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
실험적: Part-A-100 mg Cohort

Drug: IPG1094 Tablet 100 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition

실험적: Part-A-300 mg Cohort

Drug: IPG1094 Tablet 300 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition

실험적: Part-B1-50 mg QD Cohort

Drug: IPG1094 Tablet 50 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

실험적: Part-B2-100 mg QD Cohort

Drug: IPG1094 Tablet 100 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

실험적: Part-B3-200 mg QD Cohort

Drug: IPG1094 Tablet 200 mg QD, post-meal for 10 days;Drug: Matching Placebo Tablet QD, post-meal for 10 days

실험적: Part-B4-100 mg BID Optional Cohort(optional, depends on safety/PK data)

Drug: IPG1094 Tablet 100 mg BID post-meal;Drug: Matching Placebo Tablet BID post-meal

실험적: Part-C1-100 mg QD Obese Cohort

Drug: IPG1094 Tablet 100 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days

실험적: Part-C2-200 mg QD Obese Cohort

Drug: IPG1094 Tablet 200 mg QD post-meal for 28 days;Drug: Matching Placebo Tablet QD post-meal for 28 days

실험적: Part-C3-300 mg QD Obese Cohort

Drug: IPG1094 Tablet 300 mg QD post-meal for 90 days;Drug: Matching Placebo Tablet QD post-meal for 90 days

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
기간: Up to 96 hours post-dose

Single-dose maximum observed plasma concentration (Cmax) of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Time to Maximum Plasma Concentration (Tmax) of IPG1094 after single dose
기간: Up to 96 hours post-dose

Single-dose time to reach maximum plasma concentration (Tmax) of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Terminal Elimination Half-life (t1/2) of IPG1094 after single dose
기간: Up to 96 hours post-dose

Single-dose terminal elimination half-life (t1/2) of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of IPG1094 in Part A
기간: Up to 96 hours post-dose

Single-dose AUC0-t of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of IPG1094 in Part A
기간: Up to 96 hours post-dose

Single-dose AUC0-inf of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Part A: Apparent Oral Clearance (CL/F) of IPG1094 in Part A
기간: Up to 96 hours post-dose

Single-dose apparent oral clearance (CL/F) of IPG1094 following oral administration in healthy adult participants.

Up to 96 hours post-dose
Steady-State Maximum Observed Plasma Concentration (Css,max) of IPG1094 in Part B
기간: Day 1 to Day 13

Multiple-dose steady-state maximum observed plasma concentration (Css,max) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Time to Steady-State Maximum Plasma Concentration (Tss,max) of IPG1094 in Part B
기간: Day 1 to Day 13

Multiple-dose time to steady-state maximum plasma concentration (Tss,max) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Area Under the Plasma Concentration-Time Curve Over One Dosing Interval at Steady State (AUC0-τ) of IPG1094 in Part B
기간: Day 1 to Day 13

Multiple-dose steady-state AUC0-τ of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Steady-State Apparent Oral Clearance (CLss/F) of IPG1094 in Part B
기간: Day 1 to Day 13

Multiple-dose steady-state apparent oral clearance (CLss/F) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Accumulation Index Based on AUC (Rac,AUC) of IPG1094 in Part B
기간: Day 1 to Day 13

Accumulation index calculated using AUC (Rac,AUC) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Accumulation Index Based on Cmax (Rac,Cmax) of IPG1094 in Part B
기간: Day 1 to Day 13

Accumulation index calculated using Cmax(Rac,Cmax) of IPG1094 after repeated oral dosing in healthy adult participants.

Day 1 to Day 13
Safety indicators:adverse event
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

2차 결과 측정

결과 측정
기간
Part A: Safety indicators:adverse event
기간: Up to 8-day follow-up
Up to 8-day follow-up
Part B: Safety indicators:adverse event
기간: Up to Day16 follow-up
Up to Day16 follow-up
Part C: Percentage change from baseline in body weight on Day 30 for the 100 mg QD and 200 mg QD cohorts
기간: Day30 for 100/200 mg QD groups
Day30 for 100/200 mg QD groups
Part C: Percentage change from baseline in body weight on Day 90 for the 300 mg QD cohort.
기간: Day90 for 300 mg QD group
Day90 for 300 mg QD group
Part C: Changes from baseline in body weight (kg) across all scheduled visits
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Changes from baseline BMI across all scheduled visits
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Changes from baseline waist circumference across all scheduled visits
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: proportion of subjects achieving ≥5% weight loss from baseline at the endpoint assessment.
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Cmax following first and last dosing.
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Tmax following first and last dosing.
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: AUC₀-τ following the first dose and last dose
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Part C: Accumulation index
기간: Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

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)

2026년 11월 25일

기본 완료 (추정된)

2027년 6월 25일

연구 완료 (추정된)

2027년 8월 25일

연구 등록 날짜

최초 제출

2026년 10월 28일

QC 기준을 충족하는 최초 제출

2026년 11월 9일

처음 게시됨 (실제)

2026년 11월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 9일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IPG1094-HV-C002

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .