Health TrialsbyHealthPanel

IPG1094 Phase I Study for China Healthy Participants

ConditionHealthy Volunteers
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • IPG1094 Tablets

    Drug

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Part A (Single-dose & Food Effect Group)Experimental treatment 1 intervention
Group B: Part B (Multiple-dose Group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A:Time to maximum concentration (Tmax)

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.

Time frame
Full PK sampling profiles on Day 1 and Day 6
2

Part A:Plasma maximum concentration (Cmax)

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).

Time frame
Full PK sampling profiles on Day 1 and Day 6
3

Part A:Terminal elimination half-life (t1/2)

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.

Time frame
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)

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).

Time frame
Full PK sampling profiles on Day 10

Secondary outcomes

1

Safety indicators：adverse event

Time frame
PartA:From signed informed consent through Day 13 follow-up phone call PartB:From signed informed consent through Day 17 follow-up phone call

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Immunophage Biotech Co., Ltd

Lead sponsor

Shanghai Xuhui Central Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: