NCT07493031

A PhaseⅠ Study of HW252001 in Healthy Subjects

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW252001 Tablets After Single and Multiple Dosing in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomized, double-blind, placebo-controlled, Single/multiple ascending doses (SAD/MAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001.

Conditions

• IPF

Interventions

Type	Name	Description
DRUG	HW252001	HW252001 will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).
DRUG	Placebo	Placebo will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).

Timeline

• Start date: 2026-03-31
• Primary completion: 2026-12-11
• Completion: 2026-12-11
• First posted: 2026-03-25
• Last updated: 2026-03-27

Locations

1 site across 1 country: China