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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

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06897813
Enrollment
68
Registered
2025-03-27
Start date
2025-06-30
Completion date
2025-12-31
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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

Interventions

DRUGWD-910 Tablets Placebo

Administered P.O.

DRUGWD-910 tablet

Administered P.O.

Sponsors

Zhejiang Wenda Pharma Technology LTD.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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 valuesSAD ：up to 1week; MAD and FE : up to2weeks
Single Ascending Dose Cohorts : CmaxFrom Day1 to Day3
Single Ascending Dose Cohorts : AUC0-∞From Day1 to Day3
Single Ascending Dose Cohorts : TmaxFrom Day1 to Day3
Single Ascending Dose Cohorts : t½From Day1 to Day3
Multiple Ascending Dose Cohorts: Cmax,ssDay1 , Day10
Multiple Ascending Dose Cohorts: Cmin,ssDay1 , Day10
Multiple Ascending Dose Cohorts: Cavg,ssDay1 , Day10
Multiple Ascending Dose Cohorts: Tmax,ssDay1 , Day10
Multiple Ascending Dose Cohorts: AUC0-τDay1 , Day10
Multiple Ascending Dose Cohorts: t½,Day1 , Day10
Food Effect Cohorts: CmaxFrom Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: TmaxFrom Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: AUC0-tFrom Day1 to Day4 ， From Day8 to Day11

Countries

Australia

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026