Actively Recruiting
A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Led by Beijing Tide Pharmaceutical Co., Ltd · Updated on 2026-03-11
508
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
B
Beijing Tide Pharmaceutical Co., Ltd
Lead Sponsor
C
China-Japan Friendship Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with idiopathic pulmonary fibrosis (IPF) confirmed by guidelines and imaging or biopsy
- Reconfirmation of IPF diagnosis by expert imaging review before randomisation
- Aged 40 to 80 years inclusive at consent
- Willing to sign informed consent and participate voluntarily
- Agree to use highly effective contraception if of childbearing potential until 90 days after last dose
- Stable IPF disease for at least 8 weeks before first visit
- Forced expiratory volume in one second (FEV1)/FVC ratio of at least 0.70 at screening and baseline
- Forced vital capacity (FVC) percent predicted greater than 50% at screening and baseline
- Diffusing capacity of lung for carbon monoxide (DLco) percent predicted greater than 30% at screening and baseline
- Infection requiring treatment within 4 weeks prior to screening must be cured during screening
- Willing and able to comply with protocol and attend study visits
You will not qualify if you...
- Other known causes of interstitial lung disease besides IPF
- Other significant lung diseases such as asthma, COPD, or hypersensitivity pneumonitis
- Planning lung transplant within 12 months after screening
- Active tuberculosis within 12 months or active infection requiring treatment during screening
- Unstable or acute exacerbation of IPF within 8 weeks before or during screening
- Use of certain treatments within 4 weeks before randomisation including unstable IPF drugs, strong CYP3A4 inhibitors, certain CYP2C9 substrates, ROCK2 inhibitor
- History of cancer within 5 years except treated skin or cervical cancers in situ
- Moderate to severe liver insufficiency before screening
- Abnormal liver enzyme or creatine kinase levels at screening and baseline
- Uncontrolled hepatitis B or C infection at screening
- Unstable or worsening cardiac conditions within 6 months prior to screening
- Significant ECG abnormalities or family history of long QT syndrome
- High blood pressure above specified thresholds at screening and baseline
- Recent cerebrovascular event causing hospitalization within 12 months
- Reduced kidney function with creatinine clearance below 50 mL/min
- Unable to complete 6-minute walk or lung function tests
- Smoking within 3 months before screening or unwilling to quit during study
- Excessive alcohol use or unwillingness to reduce intake during study
- History of drug abuse within 6 months prior to screening
- Pregnancy or breastfeeding
- Positive HIV antibody test at screening
- Allergy to any component of TDI01 suspension
- Recent participation in other clinical studies or major surgery
- Unstable systemic or organ diseases impairing safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100023
Actively Recruiting
Research Team
H
HuaPing Dai, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here