Actively Recruiting
Adaptive, Randomised, Double-blind, Placebo-controlled Trial of TDI01 Suspension for Idiopathic Pulmonary Fibrosis
Led by Beijing Tide Pharmaceutical Co., Ltd · Updated on 2026-03-11
508
Participants Needed
1
Research Sites
21 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
Researchers are evaluating the efficacy and safety of TDI01 suspension for treating idiopathic pulmonary fibrosis (IPF) in a multicenter, randomized, double-blind, placebo-controlled, adaptive design clinical trial conducted in China. The trial includes two stages aiming to compare TDI01 with placebo in IPF patients, focusing on confirming treatment effects and safety. The study is planned for adults aged 40 to 80 years with confirmed IPF diagnosis. The study treatment involves TDI01 suspension given orally once daily at a dose of 400 mg on an empty stomach after shaking well. Both stages include a screening period, a main treatment period, an extension treatment period, and a safety visit period. Stage 1 plans to enroll 80 subjects, and Stage 2 plans to enroll 428 subjects with at least 40% receiving standard IPF therapies. The main treatment period in Stage 2 lasts 52 weeks, with the dosing and dose adjustment similar to Stage 1. Participants will undergo screening to confirm eligibility based on IPF diagnosis and lung function tests. Throughout the study, they will attend visits for assessments including lung function, safety monitoring, and outcome measurements at weeks 24 and 52. Researchers will monitor lung function parameters and other secondary outcomes, along with safety endpoints. The total participation duration includes screening, treatment, extension, and safety visits, with careful adherence to protocol requirements.
CONDITIONS
Brief 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 imaging and biopsy if available
- Aged 40 to 80 years at the time of consent
- Willing to sign informed consent and participate voluntarily
- Female or male of childbearing potential agreeing to effective contraception until 90 days after last dose
- Stable IPF disease for at least 8 weeks before first visit, with specific treatment stability criteria
- Lung function tests showing FEV1/FVC ratio ≥ 0.70, FVC% predicted > 50%, and DLco > 30%
- Active infections treated and considered cured before screening
- Able and willing to comply with study procedures and attend 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 airways obstruction (FEV1/FVC ratio < 0.7)
- Planned lung transplant within 12 months after screening
- Active tuberculosis or infections requiring systemic treatment during screening
- Unstable or worsening IPF or acute exacerbation within 8 weeks before screening
- Use of specific treatments or drugs including unstable IPF therapies and certain enzyme inhibitors within 4 weeks prior to randomisation
- History of cancer within 5 years except certain skin or cervical cancers
- Moderate to severe liver dysfunction
- Abnormal lab results exceeding defined limits
- Uncontrolled hepatitis B or C infection
- Recent unstable or worsening heart conditions
- Significant ECG abnormalities
- High blood pressure above specified limits
- Recent cerebrovascular events within 12 months
- Low kidney function (creatinine clearance < 50 mL/min)
- Unable to complete lung function or walking tests
- Recent smoking or unwillingness to stop smoking during study
- Excessive alcohol use or unwillingness to reduce intake
- Recent drug abuse
- Pregnancy or breastfeeding
- Positive HIV antibody test
- Allergy to TDI01 components
- Recent participation in other clinical trials
- Recent major surgery affecting study endpoints
- Unstable systemic or organ diseases affecting safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 52 weeks
Participants receive either TDI01 suspension or placebo once daily on an empty stomach for idiopathic pulmonary fibrosis.
Regular visits throughout the 52-week treatment period
Duration - Duration not specified
Participants attend safety visits after completing the treatment period to monitor for any adverse effects.
Safety visits following treatment completion
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100023
Actively Recruiting
Research Team
H
HuaPing Dai, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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