Tests SV001 for safety in people with idiopathic pulmonary fibrosis
Tests SV001 against a placebo in adults with idiopathic pulmonary fibrosis.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis
Key facts
- Where
- Chengdu, Guangzhou, Hangzhou, Nanchang, Nanjing, Neimeng, Shanghai, Tianjin, Xuzhou, and Zhengzhou, ChinaSee the 12 sites
- Phase
- Phase 2
Where in China
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
- Hangzhou First People's HospitalHangzhou, ChinaTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
- The Affiliated Hospital of Inner Mongolia Medical UniversityNeimeng, ChinaTaking people
- Dongfang Hospital Affiliated to Tongji UniversityShanghai, ChinaTaking people
- Huadong Hospital Affiliated to Fudan UniversityShanghai, ChinaTaking people
- Shanghai Pulmonary HospitalShanghai, ChinaTaking people
- General Hospital of Tianjin Medical UniversityTianjin, ChinaTaking people
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Synvida Biotechnology Co.,Ltd.
- Trial code
- NCT07121413
- Record updated
- 11 February 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.Read full original descriptionShow less
A Phase IIa, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
Inclusion: Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria; Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug; 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: Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization; Acute exacerbation of IPF within 4 months prior to randomization; Use of any medication known to cause or worsen pulmonary fibrosis, as assessed by the investigator, within 3 months prior to screening; History of smoking within 3 months prior to screening, or unwillingness to quit smoking throughout the study period; Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization; Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs; Presence of any other clinically significant pulmonary diseases besides IPF at screening; Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period; Evidence of renal impairment or end-stage renal disease requiring dialysis at screening; Active hepatitis virus infection; history of acquired or congenital immunodeficiency disease; History of malignancy within 5 years prior to screening; Difficulty with venipuncture or a history of needle phobia or blood phobia; Any other condition that the investigator consider unsuitable for participation in the study; Presence of specified abnormal laboratory test results at screening; Any known contraindications to performing pulmonary function tests at screening; Positive pregnancy tests or currently lactating at screening.