Clinical Trial

A Phase I Study of HW241045 in Healthy Subjects

Not Yet Recruiting Phase 1
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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 HW241045 in healthy participants. This study consists of three parts:1)Part A: A single-dose, two-period, two-way crossover design to evaluate the safety and pharmacokinetic differences between Formulation A and Formulation B of HW241045 tablets; 2)Part B: A single-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B following single administration. A food-effect study is nested within this part.3)Part C: A multiple-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B after multiple administrations.
Trial Details
NCT Number NCT07593690
Lead Sponsor Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Conditions Idiopathic Pulmonary Fibrosis (IPF)
Enrollment 102 participants
Start Date 2026-06
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-18