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Clinical Trials in China / NCT07121413
Recruiting Phase 2

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

NCT07121413 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Synvida Biotechnology Co.,Ltd.
Phase
Phase 2
Started
2025-11-04
Last updated
2026-02-11

Condition(s) studied

Idiopathic Pulmonary Fibrosis(IPF)

Investigational drug(s) / intervention(s)

SV001Placebo

SV001: SV001 : Multiple-dose

Placebo: Placebo : Multiple-dose

Study summary

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
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

More Shanghai Synvida Biotechnology Co.,Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07121413 on ClinicalTrials.gov ↗ ← All trials in China