IPG1094 Phase I Study for China Healthy Participants (NCT07679113) | Clinical Trial Compass
RecruitingPhase 1
IPG1094 Phase I Study for China Healthy Participants
China24 participantsStarted 2026-07-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A:Time to maximum concentration (Tmax)
Timeframe: Full PK sampling profiles on Day 1 and Day 6
2
Part A:Plasma maximum concentration (Cmax)
Timeframe: Full PK sampling profiles on Day 1 and Day 6
3
Part A:Terminal elimination half-life (t1/2)
Timeframe: Serial blood samples collected up to 96 hours post-dose on Day 1 and Day 6
4
Part B:Steady-state maximum plasma concentration (Css,max)
Timeframe: Full PK sampling profiles on Day 10
5
Part B:Time to steady-state maximum concentration (Tss,max)
Timeframe: Full PK sampling profiles on Day 10
6
Part B:Steady-state terminal elimination half-life (t1/2)
Timeframe: Serial blood samples collected up to 72 hours post-dose on Day 10
. 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.