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)
Incidence of Treatment-Emergent Adverse Events — Approximately 1 years Adverse event type, incidence, duration
Trial sites (12)
Facility
City
Region
Status
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
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.
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