Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults
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.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:qiaofeng qu
- 电话号码:+86 021-34782827
- 邮箱:qfqu@immunophage.com.cn
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310013
- Zhejiang Hospital
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接触:
- Wanggang Zhang, Master
- 电话号码:+86 13738194591
- 邮箱:zhangwgnian@126.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male and female Chinese participants aged 18-50 years inclusive.
- 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.
- 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.
- Female participants are non-pregnant and non-lactating.
- 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.
- 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.
- Voluntarily sign written informed consent form.
Exclusion Criteria:
- History of severe/uncontrolled cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological or psychiatric diseases with ongoing clinical significance.
- ECG: QTcF >450 ms (male) / >470 ms (female).
- Recurrent headache/migraine, recurrent nausea/vomiting.
- Blood donation ≥400 mL within 3 months before screening.
- History of orthostatic hypotension, dysphagia.
- Gastrointestinal disorders affecting drug absorption.
- Cannot comply with unified diet requirements, lactose intolerance.
- Major surgery within 3 months before screening or planned surgery during study.
- Known hypersensitivity to study drug or placebo excipients.
- Alcohol or substance abuse history; positive drug-of-abuse screen or positive alcohol breath test.
- Excessive alcohol / tobacco / caffeine intake defined per protocol.
- 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.
- Consumption of grapefruit / citrus fruits/juice within 5 days pre-screening and refusal to abstain during study.
- Vaccines or biological agents within 4 months pre-screening or planned during study.
- Participation in another interventional clinical trial within 3 months before screening.
- Difficult venous access, history of needle-phobia.
- Acute disease within 14 days prior to screening.
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
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实验性的:Part-A-100 mg Cohort
Drug: IPG1094 Tablet 100 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition |
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实验性的:Part-A-300 mg Cohort
Drug: IPG1094 Tablet 300 mg,single oral dose, fasted condition;Drug: Matching Placebo Tablet,single oral dose, fasted condition |
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实验性的: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 |
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实验性的: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 |
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实验性的: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 |
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实验性的: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 |
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实验性的: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 |
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实验性的: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 |
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实验性的: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 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
大体时间:Up to 96 hours post-dose
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Single-dose maximum observed plasma concentration (Cmax) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Time to Maximum Plasma Concentration (Tmax) of IPG1094 after single dose
大体时间:Up to 96 hours post-dose
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Single-dose time to reach maximum plasma concentration (Tmax) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Terminal Elimination Half-life (t1/2) of IPG1094 after single dose
大体时间:Up to 96 hours post-dose
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Single-dose terminal elimination half-life (t1/2) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of IPG1094 in Part A
大体时间:Up to 96 hours post-dose
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Single-dose AUC0-t of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of IPG1094 in Part A
大体时间:Up to 96 hours post-dose
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Single-dose AUC0-inf of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Part A: Apparent Oral Clearance (CL/F) of IPG1094 in Part A
大体时间:Up to 96 hours post-dose
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Single-dose apparent oral clearance (CL/F) of IPG1094 following oral administration in healthy adult participants. |
Up to 96 hours post-dose
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Steady-State Maximum Observed Plasma Concentration (Css,max) of IPG1094 in Part B
大体时间:Day 1 to Day 13
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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
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Time to Steady-State Maximum Plasma Concentration (Tss,max) of IPG1094 in Part B
大体时间:Day 1 to Day 13
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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
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Area Under the Plasma Concentration-Time Curve Over One Dosing Interval at Steady State (AUC0-τ) of IPG1094 in Part B
大体时间:Day 1 to Day 13
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Multiple-dose steady-state AUC0-τ of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Steady-State Apparent Oral Clearance (CLss/F) of IPG1094 in Part B
大体时间:Day 1 to Day 13
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Multiple-dose steady-state apparent oral clearance (CLss/F) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Accumulation Index Based on AUC (Rac,AUC) of IPG1094 in Part B
大体时间:Day 1 to Day 13
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Accumulation index calculated using AUC (Rac,AUC) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Accumulation Index Based on Cmax (Rac,Cmax) of IPG1094 in Part B
大体时间:Day 1 to Day 13
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Accumulation index calculated using Cmax(Rac,Cmax) of IPG1094 after repeated oral dosing in healthy adult participants. |
Day 1 to Day 13
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Safety indicators:adverse event
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Part A: Safety indicators:adverse event
大体时间:Up to 8-day follow-up
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Up to 8-day follow-up
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Part B: Safety indicators:adverse event
大体时间:Up to Day16 follow-up
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Up to Day16 follow-up
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Part C: Percentage change from baseline in body weight on Day 30 for the 100 mg QD and 200 mg QD cohorts
大体时间:Day30 for 100/200 mg QD groups
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Day30 for 100/200 mg QD groups
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Part C: Percentage change from baseline in body weight on Day 90 for the 300 mg QD cohort.
大体时间:Day90 for 300 mg QD group
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Day90 for 300 mg QD group
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Part C: Changes from baseline in body weight (kg) across all scheduled visits
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Changes from baseline BMI across all scheduled visits
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Changes from baseline waist circumference across all scheduled visits
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: proportion of subjects achieving ≥5% weight loss from baseline at the endpoint assessment.
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Cmax following first and last dosing.
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Tmax following first and last dosing.
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: AUC₀-τ following the first dose and last dose
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Part C: Accumulation index
大体时间:Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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Day30 for 100/200 mg QD groups;Day90 for 300 mg QD group
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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