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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: WD-890; Drug: WD-890 Tablets Placebo

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430056
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria：

• Signed Informed Consent.
• 18 Years to 50 Years (Adult).
• Body mass index (BMI) of 19 to 26 kg/m2, inclusive, and total body weight ：male >=50 kg; female >= 45.0 kg.

Exclusion Criteria：

• Has any surgery performed within 6 months prior to screening, or during the study period.
• Inability to swallow solid tablets.
• Inability to be venipunctured and tolerate venous access.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WD-890 1mg; Take a fixed dose of WD-890 tablets orally	Drug: WD-890; Administered P.O.
Experimental: WD-890 3mg; Take a fixed dose of WD-890 tablets orally	Drug: WD-890; Administered P.O.
Experimental: WD-890 6mg; Take a fixed dose of WD-890 tablets orally	Drug: WD-890; Administered P.O.
Experimental: WD-890 9mg; Take a fixed dose of WD-890 tablets orally	Drug: WD-890; Administered P.O.
Placebo Comparator: WD-890 Tablets Placebo; Take a fixed dose of WD-890 tablets Placebo orally	Drug: WD-890 Tablets Placebo; Administered P.O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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
Food Effect Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890	Days 1 to 5, Days 8 to 12,

Collaborators and Investigators

• Sponsor: Zhejiang Wenda Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: TYK2 Inhibitor
• Other Study ID Numbers: WENDA890ZQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No