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

NCT ID: NCT06897813

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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WD-910 Take a fixed dose of WD-910 tablets orally

Group Type EXPERIMENTAL

WD-910 tablet

Intervention Type DRUG

Administered P.O.

WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally

Group Type EXPERIMENTAL

WD-910 Tablets Placebo

Intervention Type DRUG

Administered P.O.

Interventions

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WD-910 tablet

Administered P.O.

Intervention Type DRUG

WD-910 Tablets Placebo

Administered P.O.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang Wenda Pharma Technology LTD.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Central Contacts

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Arockiaa Joseph

Role: CONTACT

+61 459 661 281

Facility Contacts

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Joseph

Role: primary

+61 459 661 281

Other Identifiers

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WD-910-001

Identifier Type: -

Identifier Source: org_study_id

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