NCT07121413招募中2 期
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
Shanghai Synvida Biotechnology Co.,Ltd.12 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年11月4日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 12
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Any known contraindications to performing pulmonary function tests at screening;
- •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;
- •Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period;
- •Presence of specified abnormal laboratory test results at screening;
- •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;
- •Positive pregnancy tests or currently lactating at screening;
- •Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization;
- •Any other condition that the investigator consider unsuitable for participation in the study.
研究组 & 干预措施
SV001
Experimental
干预措施: SV001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Approximately 1 years
Adverse event type, incidence, duration
次要结局
- Peak Plasma Concentration (Cmax)(Approximately 1 years)
- Peak time（Tmax）(Approximately 1 years)
- Area under the plasma concentration versus time curve (AUC)(Approximately 1 years)
- half-life（T1/2）(Approximately 1 years)
- Immunogenicity(Approximately 1 years)
研究者
研究点 (12)
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