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A Phase I Study of HW201877 in Healthy Subjects
Sponsor: Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Summary
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).
Official title: A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect of HW201877 in Healthy Volunteers.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2025-06-26
Completion Date
2026-03
Last Updated
2026-01-28
Healthy Volunteers
Yes
Interventions
HW201877 capsules
Dose 1 to Dose 7
Placebo
Dose 1 to Dose 7
Locations (1)
The First Hospital of Jilin University
Changchun, China