NCT07082842

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF

A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 472 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	HEC585	HEC585 tablet, taken once daily
DRUG	Placebo	HEC585 Simulation Board, taken once daily
DRUG	Pirfenidone	Pirfenidone, taken three times a day

Timeline

• Start date: 2025-10-09
• Primary completion: 2031-01-15
• Completion: 2032-02-15
• First posted: 2025-07-24
• Last updated: 2025-07-24

Regulatory

• FDA-regulated drug study