NCT07503587

Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis

A Randomised, Double-blind, Placebo-controlled Parallel Group Phase III Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Subjects With Progressive Pulmonary Fibrosis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with PPF . The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

Conditions

• Progressive Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	HSK44459	HSK44459 taken orally twice daily in the morning and in the evening for 52weeks.
DRUG	Placebo	Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks

Timeline

• Start date: 2026-04-05
• Primary completion: 2028-12-30
• Completion: 2029-03-01
• First posted: 2026-03-31
• Last updated: 2026-03-31