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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前:qiaofeng qu
- 電話番号:+86 021-34782827
- メール:qfqu@immunophage.com.cn
研究場所
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Zhejiang
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Hangzhou、Zhejiang、中国、310013
- Zhejiang Hospital
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コンタクト:
- Wanggang Zhang, Master
- 電話番号:+86 13738194591
- メール:zhangwgnian@126.com
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:順次割り当て
- マスキング:4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
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実験的: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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実験的: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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実験的: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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実験的: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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実験的: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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実験的: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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実験的: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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実験的: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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実験的: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 |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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二次結果の測定
二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Part A: Safety indicators:adverse event
時間枠: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
時間枠: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
時間枠: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.
時間枠: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
時間枠: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
時間枠: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
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- IPG1094-HV-C002
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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