drugset / Trial / NCT07679113

IPG1094 Phase I Study for China Healthy Participants

NCT07679113 ↗

RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2026-07-29
Primary completion
2027-01-30
Completion
2027-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject IPG1094 Unknown 200 mg Oral

Indications

No indication recorded.