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
Qualifiers
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
Treatments tested in this trial
- HW201877 capsules
- Placebo
Treatment groups
104 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov