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Completed

NCT Number: NCT06506591

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

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Key information

Conditions

Healthy Participants

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Wuhan, Hubei, 430056, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WD-890

Drug

Administered P.O.

WD-890 Tablets Placebo

Drug

Administered P.O.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  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

  13. 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

  1. Food Effect Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890

    Time frame: Days 1 to 5, Days 8 to 12,

  2. Food Effect Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890

    Time frame: Days 1 to 5, Days 8 to 12

  3. Food Effect Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890

    Time frame: Days 1 to 5, Days 8 to 12,

Sponsors and collaborators

Lead sponsor

Zhejiang Wenda Pharma Technology LTD.

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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