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
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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