A Single-And Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-890 Tablets in Healthy Chinese Subjects

NCT ID: NCT06506591

Last Updated: 2025-03-07

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2024-08-15

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-890 Tablets in Healthy Chinese Subjects

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
SAD and MAD :Double (Participant,Investigator) FE:Open Label

Study Groups

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WD-890 1mg

Take a fixed dose of WD-890 tablets orally

Group Type EXPERIMENTAL

WD-890

Intervention Type DRUG

Administered P.O.

WD-890 3mg

Take a fixed dose of WD-890 tablets orally

Group Type EXPERIMENTAL

WD-890

Intervention Type DRUG

Administered P.O.

WD-890 6mg

Take a fixed dose of WD-890 tablets orally

Group Type EXPERIMENTAL

WD-890

Intervention Type DRUG

Administered P.O.

WD-890 9mg

Take a fixed dose of WD-890 tablets orally

Group Type EXPERIMENTAL

WD-890

Intervention Type DRUG

Administered P.O.

WD-890 Tablets Placebo

Take a fixed dose of WD-890 tablets Placebo orally

Group Type PLACEBO_COMPARATOR

WD-890 Tablets Placebo

Intervention Type DRUG

Administered P.O.

Interventions

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WD-890

Administered P.O.

Intervention Type DRUG

WD-890 Tablets Placebo

Administered P.O.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent.
* 18 Years to 50 Years (Adult).
* Body mass index (BMI) of 19 to 26 kg/m2, inclusive, and total body weight :male \>=50 kg; female \>= 45.0 kg.

Exclusion Criteria

* Has any surgery performed within 6 months prior to screening, or during the study period.
* Inability to swallow solid tablets.
* Inability to be venipunctured and tolerate venous access.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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WENDA890ZQ

Identifier Type: -

Identifier Source: org_study_id

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