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

Sponsor
Beijing Tide Pharmaceutical Co., Ltd
Study ID
NCT07464912
Phase
PHASE3
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TDI01 — DRUG
    TDI01 suspension

Study Details

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.

Key Dates

Start date
Dec 24, 2025
Status verified
Mar 2026
Primary completion
Jul 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
508 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TDI01 400 mg
    400 mg, once daily, shake well before administration, orally on an empty stomach
  • Placebo Comparator: Placebo
    Once daily, shake well before administration, orally on an empty stomach

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: Week 24, Week 52. ]

Central Contacts

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