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

Zhejiang Wenda Medical Technology Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: WD-890 Tablets Placebo; Drug: WD-890

Study type: Interventional

Funder types: Other

Identifiers

NCT06506591

WENDA890ZQ

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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106 participants in 5 patient groups, including a placebo group

WD-890 1mg

Experimental group

Description:

Take a fixed dose of WD-890 tablets orally

Treatment:

Drug: WD-890

WD-890 3mg

Experimental group

Description:

Take a fixed dose of WD-890 tablets orally

Treatment:

Drug: WD-890

WD-890 6mg

Experimental group

Description:

Take a fixed dose of WD-890 tablets orally

Treatment:

Drug: WD-890

WD-890 9mg

Experimental group

Description:

Take a fixed dose of WD-890 tablets orally

Treatment:

Drug: WD-890

WD-890 Tablets Placebo

Placebo Comparator group

Description:

Take a fixed dose of WD-890 tablets Placebo orally

Treatment:

Drug: WD-890 Tablets Placebo