A Phase I Study of HW201877 in Healthy Subjects
NCT07373457 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2026-01-28
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).
Conditions
- Healthy Participants
- IBD (Inflammatory Bowel Disease)
Interventions
- DRUG
-
HW201877 capsules
Dose 1 to Dose 7
- DRUG
-
Dose 1 to Dose 7
Sponsors & Collaborators
-
Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-26
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- China
Study Locations
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