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

Zhejiang Wenda Medical Technology Co., Ltd.

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: WD-910 tablet; Drug: WD-910 Tablets Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06897813

WD-910-001

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-910 in in Healthy Participants Detailed

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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68 participants in 2 patient groups

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

Experimental group

Treatment:

Drug: WD-910 tablet

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

Experimental group

Treatment:

Drug: WD-910 Tablets Placebo