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Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults

2026年11月9日 更新者: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.

調査の概要

状態

まだ募集していません

研究の種類

介入

入学 (推定)

72

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Zhejiang
      • Hangzhou、Zhejiang、中国、310013
        • Zhejiang Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~50年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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

武器と介入

参加者グループ / アーム
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

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

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

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

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

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

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

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

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

結果測定
メジャーの説明
時間枠
Part A: Maximum Observed Plasma Concentration (Cmax) of IPG1094 after single dose
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
時間枠
Part A: Safety indicators:adverse event
時間枠:Up to 8-day follow-up
Up to 8-day follow-up
Part B: Safety indicators:adverse event
時間枠: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
時間枠: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.
時間枠: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
時間枠: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
時間枠: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
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月25日

一次修了 (推定)

2027年6月25日

研究の完了 (推定)

2027年8月25日

試験登録日

最初に提出

2026年10月28日

QC基準を満たした最初の提出物

2026年11月9日

最初の投稿 (実際)

2026年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月9日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

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