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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

ConditionHealthy Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorZhejiang Wenda Pharma Technology LTD.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Any major surgery within 12 weeks prior to Day 1, or any planned surgery during the study.

Poor pill swallowing ability

Trial design

Design model

Sequential

Treatments tested in this trial

  • WD-910 tablet

    Drug

    Administered P.O.

  • WD-910 Tablets Placebo

    Drug

    Administered P.O.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: WD-910 Take a fixed dose of WD-910 tablets orallyExperimental treatment 1 intervention
Group B: WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orallyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Number of participants with abnormal lab values

Time frame
SAD ：up to 1week; MAD and FE : up to2weeks
3

Single Ascending Dose Cohorts : Cmax

Time frame
From Day1 to Day3
4

Single Ascending Dose Cohorts : AUC0-∞

Time frame
From Day1 to Day3

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Wenda Pharma Technology LTD.

Lead sponsor

Source ClinicalTrials.gov

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