drugset / Trial / NCT05139719

A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients

NCT05139719

Phase 2 Recruiting 110 enrolled Sunshine Lake Pharma Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.

Timeline

Start
2023-02-15
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject HEC585 Small molecule Oral