NCT05465707Unknown1 期
A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multiple-dose Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of CM313 Injection in Subjects With Systemic Lupus Erythematosus
Keymed Biosciences Co.Ltd0 个研究点目标入组 40 人开始时间: 2022年10月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs).
研究概览
简要总结
A study of CM313 in subjects with systemic lupus erythematosus
详细描述
This is a multi-center, randomed, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, Pharmacokinetics and preliminary anti-tumor activity.
About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion.
The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤ 65 years old.
- •Positive autoantibody serology test at screening.
- •Contraception.
- •Voluntarily sign the ICF.
排除标准
- •With central nervous system disease caused by or not caused by SLE within 8 weeks before the first dose of study drug.
- •Possibly active Mycobacterium tuberculosis infection.
- •With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
- •Heavy drinking in the 3 months prior to screening.
- •With depression or suicidal thoughts.
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs).
时间窗: Baseline up to Day 113
Safety parameters
次要结局
未报告次要终点
研究者
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