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

NCT06506591 | Completed Phase 1

• 1 other identifier: WENDA890ZQ
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Participants

Keywords

TYK2 Inhibitor

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (3)

• 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,

Study Arms (5)

WD-890 1mg

EXPERIMENTAL

Take a fixed dose of WD-890 tablets orally

Drug: WD-890

WD-890 3mg

EXPERIMENTAL

Take a fixed dose of WD-890 tablets orally

Drug: WD-890

WD-890 6mg

EXPERIMENTAL

Take a fixed dose of WD-890 tablets orally

Drug: WD-890

WD-890 9mg

EXPERIMENTAL

Take a fixed dose of WD-890 tablets orally

Drug: WD-890

WD-890 Tablets Placebo

PLACEBO COMPARATOR

Take a fixed dose of WD-890 tablets Placebo orally

Drug: WD-890 Tablets Placebo

Interventions

WD-890 DRUG

Administered P.O.

WD-890 1mg; WD-890 3mg; WD-890 6mg; WD-890 9mg

WD-890 Tablets Placebo DRUG

Administered P.O.

WD-890 Tablets Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed Consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Wenda Pharma Technology LTD.: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430056, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: SAD and MAD ：Double (Participant,Investigator) FE：Open Label
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 17, 2024
• Study Start: October 26, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)