NCT06182969招募中1 期
A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
详细描述
This is a randomized, double-blind, placebo-controlled Phase I/II study. About 40 participants will be recruited to receive either APG-2575 or a placebo, with doses from 200mg up to 800mg.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Diagnosis of systemic lupus erythematosus for at least 6 months.
- •2. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.
- •3. SLEDIA-2000 score: 4-12
- •4.Other than systemic lupus erythematosus, subject should be in general good health.
排除标准
- •1. Severe systemic lupus erythematosus.
- •2. Significant autoimmune disease other than lupus.
- •3. Significant, uncontrolled or unstable disease in any organ.
研究组 & 干预措施
APG-2575
Experimental
Dose escalation
干预措施: APG-2575 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
时间窗: Up to 1 year
According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
次要结局
- Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000.(Up to 1 year)
- Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients.(At Day1 and Day 28 since the first dose of study drug.)
- Area under the plasma concentration versus time curve (AUC) of APG-2575 in SLE patients.(At Day1 and Day 28 since the first dose of study drug.)
- Time to Peak (Tmax) of APG-2575 in SLE patients.(At Day1 and Day 28 since the first dose of study drug.)
研究者
研究点 (1)
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