IPG1094 Phase I Study for China Healthy Participants

Официальное название

A Phase I Clinical Trial Evaluating Pharmacokinetic Characteristics of IPG 1094 in Chinese Healthy Adults

Обзор

This Phase 1 open-label study enrolls 24 healthy Chinese adults to investigate the pharmacokinetics, safety and tolerability of oral IPG1094 tablets. The trial includes two parts. Part A (12 participants) uses a crossover design to explore the impact of food on a single 200 mg dose of IPG1094; participants will receive the drug under fasting and post-meal conditions on separate days, with intensive blood sampling for PK analysis. Part B (12 participants) evaluates multiple-dose PK, where participants take 200 mg IPG1094 twice daily for 10 days to observe drug exposure and accumulation. All participants will undergo comprehensive safety checks such as lab tests, ECG and adverse event monitoring during screening, treatment and post-dosing follow-up. No placebo or blinding is applied in this study.

Вмешательства

• Препарат IPG1094 Tablets
  Part A:Oral administration with 240 mL water; fasted: ≥10h overnight fast, no water 1h before/after dosing; fed: take drug within 30 mins of finishing standardized high-fat breakfast. Single dose 200 mg per cycle, two cycles separated by 5-day washout. Part B:Oral 200 mg twice daily, morning \& evening, continuous 10 days; each dose taken with 240 mL water, restricted water intake 1h pre/post dose; steady-state PK sampling for accumulation assessment.

Первичные конечные точки

• Part A:Time to maximum concentration (Tmax) [Срок оценки: Full PK sampling profiles on Day 1 and Day 6]
• Part A:Plasma maximum concentration (Cmax) [Срок оценки: Full PK sampling profiles on Day 1 and Day 6]
• Part A:Terminal elimination half-life (t1/2) [Срок оценки: Serial blood samples collected up to 96 hours post-dose on Day 1 and Day 6]
• Part B:Steady-state maximum plasma concentration (Css,max) [Срок оценки: Full PK sampling profiles on Day 10]
• Part B:Time to steady-state maximum concentration (Tss,max) [Срок оценки: Full PK sampling profiles on Day 10]
• Part B:Steady-state terminal elimination half-life (t1/2) [Срок оценки: Serial blood samples collected up to 72 hours post-dose on Day 10]

Вторичные конечные точки (1)

• Safety indicators：adverse event [Срок оценки: PartA:From signed informed consent through Day 13 follow-up phone call PartB:From signed informed consent through Day 17 follow-up phone call]

Критерии участия

Критерии включения

• Male and female healthy Chinese participants aged 18 to 50 years (inclusive).
• Comprehensive assessments including physical examination, vital signs, 12-lead ECG, chest X-ray and laboratory tests are normal or with abnormalities judged not clinically significant by the investigator.
• Body weight: Male ≥50.0 kg, Female ≥45.0 kg; Body Mass Index (BMI) ranges from 19.0 to 26.0 (inclusive). BMI = Weight(kg) / Height(m)².
• Female participants are non-pregnant and non-lactating.
• Participants have no pregnancy plan and no sperm/egg donation plan from 2 weeks before screening to 6 months after the end of the study, and agree to use effective contraception during this period.
• Voluntarily sign the written informed consent form, and fully understand the trial content and potential adverse reactions.

Критерии исключения

• History of severe cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, psychiatric or other systemic diseases with clinical significance.
• QTcF interval >450 ms (male) or >470 ms (female).
• History of recurrent headache, nausea or vomiting.
• Blood loss ≥400 mL within 3 months before screening, or plan to donate blood during the study.
• History of orthostatic hypotension or dysphagia.
• History of gastrointestinal diseases affecting drug absorption.
• Lactose intolerance, special dietary restrictions, or unable to follow unified diet requirements during the trial.
• History of drug/food allergy, drug abuse or alcohol abuse.
• Heavy smoking, excessive intake of tea, coffee or caffeinated beverages within 3 months before screening.
• Use of any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicines within 14 days before screening.
• Use of drugs affecting liver metabolism or gastrointestinal environment within 30 days before screening.
• Intake of citrus fruits/juices within 5 days before screening or during the trial.
• Participated in other clinical trials within 3 months before screening.
• Positive result of urine drug screen or breath alcohol test at admission.
• Difficulty in venous blood collection, history of syncope during blood collection.
• Acute illness before screening, or other conditions judged inappropriate for participation by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Xuhui Central Hospital — Шанхай

Идентификаторы

NCT: NCT07679113 · IPG1094-HV-C001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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