MedTrace Logo

IPG1094 Phase I Study for China Healthy Participants

NCT07679113 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

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.

Sponsors & Collaborators

  • Shanghai Xuhui Central Hospital

    collaborator UNKNOWN

  • Nanjing Immunophage Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679113 on ClinicalTrials.gov