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

Shanghai Synvida Biotechnology

Status and phase: Not yet enrolling; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis(IPF)

Treatments: Drug: SV001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07121413

SV001-201

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

SV001

Experimental group

Treatment:

Drug: SV001

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo