A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

This study is a multicentre, randomised, double-blind, placebo-controlled, adaptive design clinical trial to evaluate the efficacy and safety of TDI01 suspension in the treatment of idiopathic pulmonary fibrosis (IPF). The study will be conducted in China and divided into two stages, both of which are multicentre, randomised, double-blind, placebo-controlled studies. Stage 1 aims to evaluate the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients, and Stage 2 aims to further confirm the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients.

NCT Number	NCT07464912
Lead Sponsor	Beijing Tide Pharmaceutical Co., Ltd Collaborators: China-Japan Friendship Hospital
Conditions	Idiopathic Pulmonary Fibrosis (IPF)
Enrollment	508 participants
Start Date	2025-12-24
Primary Completion	2029-07-30 (estimated)
Study Completion	2029-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-11