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

March 26, 2025 updated by: Zhejiang Wenda Medical Technology Co., Ltd.
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WD-910 Take a fixed dose of WD-910 tablets orally
Drug: WD-910 tablet
Administered P.O.
Experimental: WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally
Drug: WD-910 Tablets Placebo
Administered P.O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with abnormal lab values
Time Frame: SAD ：up to 1week; MAD and FE : up to2weeks
SAD ：up to 1week; MAD and FE : up to2weeks
Single Ascending Dose Cohorts : Cmax
Time Frame: From Day1 to Day3
From Day1 to Day3
Single Ascending Dose Cohorts : AUC0-∞
Time Frame: From Day1 to Day3
From Day1 to Day3
Single Ascending Dose Cohorts : Tmax
Time Frame: From Day1 to Day3
From Day1 to Day3
Single Ascending Dose Cohorts : t½
Time Frame: From Day1 to Day3
From Day1 to Day3
Multiple Ascending Dose Cohorts: Cmax,ss
Time Frame: Day1 , Day10
Day1 , Day10
Multiple Ascending Dose Cohorts: Cmin,ss
Time Frame: Day1 , Day10
Day1 , Day10
Multiple Ascending Dose Cohorts: Cavg,ss
Time Frame: Day1 , Day10
Day1 , Day10
Multiple Ascending Dose Cohorts: Tmax,ss
Time Frame: Day1 , Day10
Day1 , Day10
Multiple Ascending Dose Cohorts: AUC0-τ
Time Frame: Day1 , Day10
Day1 , Day10
Multiple Ascending Dose Cohorts: t½,
Time Frame: Day1 , Day10
Day1 , Day10
Food Effect Cohorts: Cmax
Time Frame: From Day1 to Day4 ， From Day8 to Day11
From Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: Tmax
Time Frame: From Day1 to Day4 ， From Day8 to Day11
From Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: AUC0-t
Time Frame: From Day1 to Day4 ， From Day8 to Day11
From Day1 to Day4 ， From Day8 to Day11
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
A single-ascending dose (SAD) study ：up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Urine/feces metabolites identification
Time Frame: From Day1 to Day4 ， From Day8 to Day11
From Day1 to Day4 ， From Day8 to Day11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Wenda Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2025

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • WD-910-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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