IPG1094 Phase I Study for China Healthy Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNanjing Immunophage Biotech Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • IPG1094 Tablets

Treatment groups

24 Participants
are divided into 2 treatment groups

Locations

1
Shanghai Xuhui Central Hospital200031, ShanghaiXuhui, China

Sponsors and collaborators

Nanjing Immunophage Biotech Co., Ltd

Lead sponsor

Shanghai Xuhui Central Hospital

Collaborator