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This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-890 Tablets in Healthy Chinese Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WD-890 1mg | Experimental | Take a fixed dose of WD-890 tablets orally |
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| WD-890 3mg | Experimental | Take a fixed dose of WD-890 tablets orally |
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| WD-890 6mg | Experimental | Take a fixed dose of WD-890 tablets orally |
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| WD-890 9mg | Experimental | Take a fixed dose of WD-890 tablets orally |
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| WD-890 Tablets Placebo | Placebo Comparator | Take a fixed dose of WD-890 tablets Placebo orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WD-890 | Drug | Administered P.O. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of a single oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations | Days 1 to 5 | |
| Tolerability of a single oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations | Days 1 to 5 | |
| Safety of a multiple oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations | Days 1 to 19 | |
| Tolerability of a multiple oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations | Days 1 to 19 | |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Maximum Observed Plasma Concentration (Cmax) of WD-890； | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12; FE: Days 1 to 5, Days 8 to 12 | |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of WD-890 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 FE: Days 1 to 5, Days 8 to 12 | |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of WD-890 |
| Measure | Description | Time Frame |
|---|---|---|
| Food Effect Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890 | Days 1 to 5, Days 8 to 12, | |
| Food Effect Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890 | Days 1 to 5, Days 8 to 12 |
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Inclusion Criteria：
Exclusion Criteria：
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430056 | China |
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SAD and MAD ：Double (Participant,Investigator) FE：Open Label
| WD-890 Tablets Placebo | Drug | Administered P.O. |
|
| SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 FE: Days 1 to 5, Days 8 to 12 |
| Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 |
| Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 |
| Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890 | SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 |
| Multiple Ascending Dose (MAD) Cohorts: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of WD-890 | Day 1, Day 6, Day 9 and Day 12 |
| Multiple Ascending Dose (MAD) Cohorts: Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss) of WD-890 | Day 1, Day 6, Day 9 and Day 12 |
| Multiple Ascending Dose (MAD) Cohorts: Apparent Volume of Distribution at Steady State (Vss/F) of WD-890 | Day 1, Day 6, Day 9 and Day 12 |
| Food Effect Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890 | Days 1 to 5, Days 8 to 12, |