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

Phase 1

Not yet recruiting

• Conditions: Healthy Participants
• Interventions: Drug: WD-910 tablet; Drug: WD-910 Tablets Placebo

• Registration Number: NCT06897813
• 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-910 in in Healthy Participants Detailed

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-04-02
• Study Start: 2025-06-30
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
WD-910 Take a fixed dose of WD-910 tablets orally	WD-910 tablet	-
WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally	WD-910 Tablets Placebo	-

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events (AEs)	A single-ascending dose (SAD) study ：up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks
Number of participants with abnormal lab values	SAD ：up to 1week; MAD and FE : up to2weeks
Single Ascending Dose Cohorts : Cmax	From Day1 to Day3
Single Ascending Dose Cohorts : AUC0-∞	From Day1 to Day3
Single Ascending Dose Cohorts : Tmax	From Day1 to Day3
Single Ascending Dose Cohorts : t½	From Day1 to Day3
Multiple Ascending Dose Cohorts: Cmax,ss	Day1 , Day10
Multiple Ascending Dose Cohorts: Cmin,ss	Day1 , Day10
Multiple Ascending Dose Cohorts: Cavg,ss	Day1 , Day10
Multiple Ascending Dose Cohorts: Tmax,ss	Day1 , Day10
Multiple Ascending Dose Cohorts: AUC0-τ	Day1 , Day10
Multiple Ascending Dose Cohorts: t½,	Day1 , Day10
Food Effect Cohorts: Cmax	From Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: Tmax	From Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: AUC0-t	From Day1 to Day4 ， From Day8 to Day11

Trial Locations

Locations (1)

Nucleus Network Pty Ltd; 🇦🇺 Melbourne, Victoria, Australia