SV001 for safety, tolerability, and immune response in people with idiopathic pulmonary fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study in people with confirmed idiopathic pulmonary fibrosis that compares SV001 with a placebo to gather safety, tolerability, pharmacokinetic, and immunogenicity data. Participants will receive either SV001 or placebo and attend scheduled clinic visits for blood sampling, pulmonary function testing, and safety monitoring. Key enrollment criteria include meeting protocol-specified lung function thresholds and agreement to contraception requirements; patients with other significant lung diseases, recent infections, or recent IPF exacerbations are excluded. The primary goal is to characterize how the drug is tolerated and processed by the body to inform dosing and future studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;
2. Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug;
3. Subjucts must be able to understand the study, voluntarily provide written informed consent, and be willing and able to comply with all study-related procedures.

Exclusion Criteria:

1. Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs;
2. Presence of any other clinically significant pulmonary diseases besides IPF at screening;
3. Any known contraindications to performing pulmonary function tests at screening;
4. Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization;
5. Acute exacerbation of IPF within 4 months prior to randomization;
6. Use of any medication known to cause or worsen pulmonary fibrosis, as assessed by the investigator, within 3 months prior to screening;
7. History of smoking within 3 months prior to screening, or unwillingness to quit smoking throughout the study period;
8. Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period;
9. Presence of specified abnormal laboratory test results at screening;
10. Evidence of renal impairment or end-stage renal disease requiring dialysis at screening;
11. Active hepatitis virus infection; history of acquired or congenital immunodeficiency disease;
12. History of malignancy within 5 years prior to screening;
13. Difficulty with venipuncture or a history of needle phobia or blood phobia;
14. Positive pregnancy tests or currently lactating at screening;
15. Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization;
16. Any other condition that the investigator consider unsuitable for participation in the study.

Where it's running

• Sichuan Provincial People's Hospital
  Chengdu, China Recruiting
• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, China Recruiting
• Hangzhou First People's Hospital
  Hangzhou, China Recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, China Recruiting
• Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
  Nanjing, China Recruiting
• The Affiliated Hospital of Inner Mongolia Medical University
  Neimeng, China Recruiting

Study contacts

• Study coordinator: Jinfu Xu
• Email: hdyyll@126.com
• Phone: 86-21-62483180

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.