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NCT Number: NCT06897813

A Phase I Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-910 in Healthy Participants

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-910 in in Healthy Participants Detailed

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 to 55 years (inclusive) at the time of informed consent.
  • Body mass index (BMI) between 18 to 32 kg/m2 and male participant with body weight of ≥ 50.0 kg, female participant with body weight ≥ 45.0 kg

Exclusion criteria

  • Any major surgery within 12 weeks prior to Day 1, or any planned surgery during the study.
  • Poor pill swallowing ability

Treatment and study plan

WD-910 tablet

Drug

Administered P.O.

WD-910 Tablets Placebo

Drug

Administered P.O.

Primary outcomes

  1. The incidence of adverse events (AEs)

    Time frame: A single-ascending dose (SAD) study ：up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks

  2. Number of participants with abnormal lab values

    Time frame: SAD ：up to 1week; MAD and FE : up to2weeks

  3. Single Ascending Dose Cohorts : Cmax

    Time frame: From Day1 to Day3

  4. Single Ascending Dose Cohorts : AUC0-∞

    Time frame: From Day1 to Day3

  5. Single Ascending Dose Cohorts : Tmax

    Time frame: From Day1 to Day3

  6. Single Ascending Dose Cohorts : t½

    Time frame: From Day1 to Day3

  7. Multiple Ascending Dose Cohorts: Cmax,ss

    Time frame: Day1 , Day10

  8. Multiple Ascending Dose Cohorts: Cmin,ss

    Time frame: Day1 , Day10

  9. Multiple Ascending Dose Cohorts: Cavg,ss

    Time frame: Day1 , Day10

  10. Multiple Ascending Dose Cohorts: Tmax,ss

    Time frame: Day1 , Day10

  11. Multiple Ascending Dose Cohorts: AUC0-τ

    Time frame: Day1 , Day10

  12. Multiple Ascending Dose Cohorts: t½,

    Time frame: Day1 , Day10

  13. Food Effect Cohorts: Cmax

    Time frame: From Day1 to Day4 ， From Day8 to Day11

  14. Food Effect Cohorts: Tmax

    Time frame: From Day1 to Day4 ， From Day8 to Day11

  15. Food Effect Cohorts: AUC0-t

    Time frame: From Day1 to Day4 ， From Day8 to Day11

Study contacts

Contact information is provided by the study sponsor or research team.

Arockiaa Joseph

CONTACT

[email protected]

+61 459 661 281

Sponsors and collaborators

Lead sponsor

Zhejiang Wenda Pharma Technology LTD.

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Apr 2, 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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