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

A Phase IIa, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis

This trial will test whether SV001 is safe, well tolerated, and how it behaves in the body in people with idiopathic pulmonary fibrosis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Shanghai Synvida Biotechnology Co.,Ltd. (Industry-sponsored)
• Locations: 12 sites (Chengdu and 11 other locations)
• Trial ID: NCT07121413 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of idiopathic pulmonary fibrosis who meet the study's pulmonary function criteria and can comply with study visits and contraception requirements are ideal candidates.

Not a fit: Patients with other significant pulmonary diseases, recent respiratory infections, recent IPF exacerbation, known allergies to study drugs, or who cannot comply with contraception are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SV001 could become a new treatment option that is safe and helps guide future studies aiming to slow IPF progression.

How similar studies have performed: While approved drugs like pirfenidone and nintedanib can slow IPF progression, SV001 is an investigational agent and similar safety/PK studies are an early step without proven late-stage success for this specific agent.

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.

Where this trial is running

Chengdu and 11 other locations

• 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)
• Dongfang Hospital Affiliated to Tongji University — Shanghai, China (Recruiting)
• Huadong Hospital Affiliated to Fudan University — Shanghai, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)
• General Hospital of Tianjin Medical University — Tianjin, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Jinfu Xu

Conditions Idiopathic Pulmonary Fibrosis