A Phase I Clinical Trial Evaluating Pharmacokinetic Characteristics of IPG 1094 in Chinese Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Part B:Time to steady-state maximum concentration (Tss,max)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Part A (Single-dose & Food Effect Group)
Randomized open-label 2-way crossover single 200 mg IPG1094 tablet, evaluate food effect on PK; 6 subjects fast→fed, 6 subjects fed→fast.
干预措施: IPG1094 Tablets (Drug)
Part B (Multiple-dose Group)
Open-label multiple-dose IPG1094 200 mg BID oral for 10 consecutive days to assess steady-state PK, safety and tolerability.
干预措施: IPG1094 Tablets (Drug)
结局指标
主要结局
Part B:Time to steady-state maximum concentration (Tss,max)
时间窗: Full PK sampling profiles on Day 10
The time elapsed after the Day 10 morning dose to reach steady-state peak concentration (Css,max), presented as descriptive statistics.
Part A:Time to maximum concentration (Tmax)
时间窗: Full PK sampling profiles on Day 1 and Day 6
The time elapsed from IPG1094 administration to the occurrence of Cmax under fasting and high-fat fed states, summarized by median values per treatment sequence.
Part A:Plasma maximum concentration (Cmax)
时间窗: Full PK sampling profiles on Day 1 and Day 6
The maximum observed plasma concentration of IPG1094 after a single 200 mg oral dose under fasting and high-fat fed conditions, calculated via non-compartmental analysis (NCA).
Part A:Terminal elimination half-life (t1/2)
时间窗: Serial blood samples collected up to 96 hours post-dose on Day 1 and Day 6
Description: Terminal elimination half-life of IPG1094 following single-dose administration in fasting and high-fat fed regimens, derived from the terminal log-linear elimination phase of concentration-time curves.
Part B:Steady-state maximum plasma concentration (Css,max)
时间窗: Full PK sampling profiles on Day 10
The maximum observed steady-state plasma concentration of IPG1094 after continuous twice-daily 200 mg dosing for 10 days, calculated via non-compartmental analysis (NCA).
Part B:Steady-state terminal elimination half-life (t1/2)
时间窗: Serial blood samples collected up to 72 hours post-dose on Day 10
Terminal elimination half-life of IPG1094 at steady state after repeated twice-daily dosing, calculated from the log-linear terminal elimination phase of Day 10 concentration-time curve.
次要结局
- Safety indicators：adverse event(PartA:From signed informed consent through Day 13 follow-up phone call PartB:From signed informed consent through Day 17 follow-up phone call)