A Phase 1 interventional study of HW241045 Formulation A and HW241045 Formulation B in Idiopathic Pulmonary Fibrosis (IPF), sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. · Phase 1, Interventional, and Treatment
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.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's planned enrollment of 102 is above the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. is the lead sponsor of 8 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: HW241045 Formulation A
Drug: HW241045 Formulation B
Drug: Placebo
Single-dose administration in Part A.
Single-dose administration in Part A;Single-dose administration in Part B, with 4 dose groups;Multiple-dose administration in Part C, with 3 dose groups.
Single-dose administration in Part B, with 4 dose groups;Multiple-dose administration in Part C, with 3 dose groups.
The number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of single or multiple oral dose of HW241045 in healthy participants.
Time frame: From the first dose administration to 48 hours after the last dose.
Plan to share: No
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis→
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.