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

Not Applicable

Not yet recruiting

• Conditions: Idiopathic Pulmonary Fibrosis(IPF)
• Interventions: Drug: SV001; Drug: Placebo

• Registration Number: NCT07121413
• Lead Sponsor: Shanghai Synvida Biotechnology Co.,Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-08-31
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SV001	SV001	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Approximately 1 years	Adverse event type, incidence, duration

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	Approximately 1 years	PK (Pharmacokinetics)
Peak time（Tmax）	Approximately 1 years	PK (Pharmacokinetics)
Area under the plasma concentration versus time curve (AUC)	Approximately 1 years	PK (Pharmacokinetics)
half-life（T1/2）	Approximately 1 years	PK (Pharmacokinetics)
Immunogenicity	Approximately 1 years	ADA（Anti-drug antibody）

Trial Locations

Locations (1)

Huadong Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, China