A Single-And Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-890 Tablets in Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: WD-890 Tablets Placebo; Drug: WD-890

• Registration Number: NCT06506591
• Lead Sponsor: Zhejiang Wenda Medical Technology Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-26
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-17
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
WD-890 Tablets Placebo	WD-890 Tablets Placebo	Take a fixed dose of WD-890 tablets Placebo orally
WD-890 3mg	WD-890	Take a fixed dose of WD-890 tablets orally
WD-890 9mg	WD-890	Take a fixed dose of WD-890 tablets orally
WD-890 1mg	WD-890	Take a fixed dose of WD-890 tablets orally
WD-890 6mg	WD-890	Take a fixed dose of WD-890 tablets orally

Primary Outcome Measures

Name	Time	Method
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
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) 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
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
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	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 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

Secondary Outcome Measures

Name	Time	Method
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,

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China