A Phase I Study of HW201877 in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorWuhan Humanwell Innovative Drug Research and Development Center Limited Company
About this trial
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Before enrollment in the study, each subject shall sign the informed consent form and be fully apprised of the study content, implementation procedures and potential adverse reactions.
Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 6 months after the last dose administration.
18 years to 55 years (inclusive), male and female.
Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-28 kg/m2 (inclusive) .
Disqualifiers
Smoking more than 5 cigarettes per day within 3 months prior to screening.
Allergic diathesis (with a history of allergies to multiple drugs and foods).
A history of drug abuse and/or alcoholism (consuming 14 units of alcohol per week; 1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine).
Have taken any medications that alter hepatic enzyme activity within 28 days prior to screening.
Trial design
Design model
Parallel
Treatments tested in this trial
HW201877 capsules
DrugDose 1 to Dose 7
Placebo
DrugDose 1 to Dose 7
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: HW201877 capsulesExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of single or multiple oral dose of HW201877 in healthy adult volunteers
Time frame
Day 1 to Day 5Sponsors and contacts
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Source ClinicalTrials.gov