A Single-And Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics,Pharmacodynamics and Food Effect of WD-890 Tablets in Healthy Chinese Subjects
Overview
- Phase
- Phase 1
- Intervention
- WD-890
- Conditions
- Healthy Participants
- Sponsor
- Zhejiang Wenda Medical Technology Co., Ltd.
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
WD-890 1mg
Take a fixed dose of WD-890 tablets orally
Intervention: WD-890
WD-890 3mg
Take a fixed dose of WD-890 tablets orally
Intervention: WD-890
WD-890 6mg
Take a fixed dose of WD-890 tablets orally
Intervention: WD-890
WD-890 9mg
Take a fixed dose of WD-890 tablets orally
Intervention: WD-890
WD-890 Tablets Placebo
Take a fixed dose of WD-890 tablets Placebo orally
Intervention: WD-890 Tablets Placebo
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: 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
Time Frame: 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；
Time Frame: 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: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890
Time Frame: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12
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
Time Frame: Days 1 to 5
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Day 1, Day 6, Day 9 and Day 12
Secondary Outcomes
- 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)
- Food Effect Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890(Days 1 to 5, Days 8 to 12,)