NCT07121413 A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis
| NCT ID | NCT07121413 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Synvida Biotechnology Co.,Ltd. |
| Condition | Idiopathic Pulmonary Fibrosis(IPF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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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 wors