Actively Recruiting
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis
Led by Shanghai Synvida Biotechnology Co.,Ltd. · Updated on 2026-02-11
48
Participants Needed
12
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) with pulmonary function meeting study criteria
- Agree to use highly effective contraception during the study and for 6 months after last dose
- Able to understand the study, provide written informed consent, and comply with all study procedures
You will not qualify if you...
- History of drug or other allergies or potential allergy to study drugs
- Presence of any other significant pulmonary diseases besides IPF
- Known contraindications to pulmonary function tests
- 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 medications known to cause or worsen pulmonary fibrosis within 3 months prior to screening
- History of smoking within 3 months prior to screening or unwilling to quit smoking during study
- Significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic diseases
- Plans for major surgery during the study period
- Abnormal specified laboratory test results at screening
- Evidence of renal impairment or end-stage renal disease requiring dialysis
- Active hepatitis virus infection or history of immunodeficiency disease
- History of malignancy within 5 years prior to screening
- Difficulty with venipuncture or history of needle or blood phobia
- Positive pregnancy test or currently lactating at screening
- Participation in another clinical trial and use of investigational drugs within 3 months prior to randomization
- Any other condition considered unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Sichuan Provincial People's Hospital
Chengdu, China
Actively Recruiting
2
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
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3
Hangzhou First People's Hospital
Hangzhou, China
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4
The First Affiliated Hospital of Nanchang University
Nanchang, China
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5
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
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6
The Affiliated Hospital of Inner Mongolia Medical University
Neimeng, China
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7
Dongfang Hospital Affiliated to Tongji University
Shanghai, China
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8
Huadong Hospital Affiliated to Fudan University
Shanghai, China
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9
Shanghai Pulmonary Hospital
Shanghai, China
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10
General Hospital of Tianjin Medical University
Tianjin, China
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11
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
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12
Henan Provincial People's Hospital
Zhengzhou, China
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Research Team
J
Jinfu Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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