NCT07121413 A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 48 participants in total. It began in 2025-11-04 with a primary completion date of 2026-12-31.

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.

Eligibility Criteria

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.

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