NCT06764862

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	HSK44459 dose 1	HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
DRUG	HSK44459 dose 2	HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
DRUG	HSK44459 dose 3	HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.
DRUG	Placebo	Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks.

Timeline

• Start date: 2025-01-17
• Primary completion: 2026-02-12
• Completion: 2026-03-04
• First posted: 2025-01-09
• Last updated: 2026-04-13

Locations

1 site across 1 country: China