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 1Not Yet RecruitingNCT06897813

Zhejiang Wenda Pharma Technology LTD.68 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Participants

Interventions

WD-910 tabletDRUG

Administered P.O.

WD-910 Tablets PlaceboDRUG

Administered P.O.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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

Multiple Ascending Dose Cohorts: AUC0-τ

Time frame: Day1 , Day10

Multiple Ascending Dose Cohorts: t½,

Time frame: Day1 , Day10

Central Contacts

Arockiaa Joseph

CONTACT

+61 459 661 281 c.trollip@nucleusnetwork.com.au

Data from ClinicalTrials.gov

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