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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Hangzhou First People's Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITING
Neimeng
Dongfang Hospital Affiliated to Tongji University
RECRUITING
Shanghai
Huadong Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
General Hospital of Tianjin Medical University
RECRUITING
Tianjin
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jinfu Xu
hdyyll@126.com
86-21-62483180
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 48
Treatments
Experimental: SV001
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Shanghai Synvida Biotechnology Co.,Ltd.