NCT07373457

A Phase I Study of HW201877 in Healthy Subjects

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Wuhan Humanwell Innovative Drug Research and Development Center Limited Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	HW201877 capsules	Dose 1 to Dose 7
DRUG	Placebo	Dose 1 to Dose 7

Timeline

• Start date: 2025-06-26
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: China