A Clinical Trial on the Treatment of Idiopathic Pulmonary Fibrosis

Status Not yet recruiting

Clinical Trial Summary

This trial was performed in patients with idiopathic pulmonary fibrosis (IPF) to evaluate the clinical efficacy and safety of different doses of TDI01 Suspension, compared with control, for the treatment of patients with IPF.

Clinical Trial Description

This is a Phase II, multi-center, randomized, double-blinded, placebo-controlled clinical study to evaluate the efficacy and safety of TDI01 Suspension for the treatment of IPF. The study consists of a 4-week screening period, a 24-week treatment period, a 28-week extension period, and a 2-week safety follow-up period. It is planned to include 120 IPF patients. All subjects will be randomized in a 1:1:1 ratio to receive a 24-week treatment with TDI01 Suspension dosage A, TDI01 Suspension dosage B, or the placebo. At Week 24, the subjects will be evaluated for the primary efficacy endpoints and subsequently enter the extension period. Subjects may continue receiving the investigational product until Week 52 at their voluntary consent. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06102083
Study type	Interventional
Source	Beijing Tide Pharmaceutical Co., Ltd
Contact	Dai HuaPing, MD
Phone	010-84206278
Email	daihuaping@ccmu.edu.cn
Status	Not yet recruiting
Phase	Phase 2
Start date	November 2, 2023
Completion date	March 1, 2026

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