Not yet recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WD-910 tablet, WD-910 Tablets Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug WD-910 tablet
Administered P.O. - Drug WD-910 Tablets Placebo
Administered P.O.
Primary outcome measures
- 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]
- Number of participants with abnormal lab values [Time frame: SAD ：up to 1week; MAD and FE : up to2weeks]
- Single Ascending Dose Cohorts : Cmax [Time frame: From Day1 to Day3]
- Single Ascending Dose Cohorts : AUC0-∞ [Time frame: From Day1 to Day3]
- Single Ascending Dose Cohorts : Tmax [Time frame: From Day1 to Day3]
- Single Ascending Dose Cohorts : t½ [Time frame: From Day1 to Day3]
- Multiple Ascending Dose Cohorts: Cmax,ss [Time frame: Day1 , Day10]
- Multiple Ascending Dose Cohorts: Cmin,ss [Time frame: Day1 , Day10]
- Multiple Ascending Dose Cohorts: Cavg,ss [Time frame: Day1 , Day10]
- Multiple Ascending Dose Cohorts: Tmax,ss [Time frame: Day1 , Day10]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Australia · 1 center
- Nucleus Network Pty Ltd — Melbourne
Identifiers
NCT: NCT06897813 · WD-910-001