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

NCT ID: NCT07121413

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 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.

Conditions

Idiopathic Pulmonary Fibrosis(IPF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SV001

Group Type: EXPERIMENTAL

SV001

Intervention Type: DRUG

SV001 ： Multiple-dose

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo ： Multiple-dose

Interventions

SV001

SV001 ： Multiple-dose

Intervention Type: DRUG

Placebo

Placebo ： Multiple-dose

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Synvida Biotechnology Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huadong Hospital Affiliated to Fudan University

Shanghai, , China

Countries

China

Central Contacts

Jinfu Xu

Role: CONTACT

hdyyll@126.com

86-21-62483180

Facility Contacts

Jinfu Xu

Role: primary

hdyyll@126.com

86-21-62483180

Other Identifiers

SV001-201

Identifier Type: -

Identifier Source: org_study_id