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| Name | Class |
|---|---|
| Shanghai Xuhui Central Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (Single-dose & Food Effect Group) | Experimental | Randomized open-label 2-way crossover single 200 mg IPG1094 tablet, evaluate food effect on PK; 6 subjects fast→fed, 6 subjects fed→fast. |
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| Part B (Multiple-dose Group) | Experimental | Open-label multiple-dose IPG1094 200 mg BID oral for 10 consecutive days to assess steady-state PK, safety and tolerability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Full PK sampling profiles on Day 1 and Day 6 |
| 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). | Full PK sampling profiles on Day 1 and Day 6 |
| 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. | Serial blood samples collected up to 96 hours post-dose on Day 1 and Day 6 |
| 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). | Full PK sampling profiles on Day 10 |
| Part B:Time to steady-state maximum concentration (Tss,max) | The time elapsed after the Day 10 morning dose to reach steady-state peak concentration (Css,max), presented as descriptive statistics. | Full PK sampling profiles on Day 10 |
| Part B:Steady-state terminal elimination half-life (t1/2) | Terminal elimination half-life of IPG1094 at steady state after repeated twice-daily dosing, calculated from the log-linear terminal elimination phase of Day 10 concentration-time curve. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety indicators:adverse event | PartA:From signed informed consent through Day 13 follow-up phone call PartB:From signed informed consent through Day 17 follow-up phone call |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anzhu Yu | Contact | +86-21-34782827 | azyu@immunophage.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Xuhui | 200031 | China |
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| Serial blood samples collected up to 72 hours post-dose on Day 10 |