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
1 other identifier
interventional
68
1 country
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-910 in in Healthy Participants Detailed
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2025
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2025
CompletedStudy Start
First participant enrolled
June 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 2, 2025
March 1, 2025
4 months
March 4, 2025
March 26, 2025
Conditions
Outcome Measures
Primary Outcomes (15)
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
Study Arms (2)
WD-910 Take a fixed dose of WD-910 tablets orally
EXPERIMENTALWD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally
EXPERIMENTALInterventions
Administered P.O.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any major surgery within 12 weeks prior to Day 1, or any planned surgery during the study.
- Poor pill swallowing ability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004, Australia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2025
First Posted
March 27, 2025
Study Start
June 30, 2025
Primary Completion
October 31, 2025
Study Completion
December 31, 2025
Last Updated
April 2, 2025
Record last verified: 2025-03