A Single-center, Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Proximod in Healthy Subjects and Patients With Rheumatoid Arthritis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Time to peak plasma concentration (Tmax)
研究概览
简要总结
The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects and patients with rheumatoid arthritis. The main questions it arms to answer are:
- to evaluate the safety and tolerance of Proximod in health subjects after repeated doses.
- to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses.
- to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis.
- to evaluate the pharmacokinetics and pharmacodynamics of Proximod in patients with rheumatoid arthritis.
Participants will receive test tablets or placebo at the indicated date and collect blood samples.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo, qd, oral administration for 28 days
干预措施: Placebo (Drug)
Proximod
Proximod Tablets, 5mg, qd, oral administration for 28 days
干预措施: Proximod (Drug)
结局指标
主要结局
Time to peak plasma concentration (Tmax)
时间窗: Up to 48 days
Number of adverse events and number of participants with adverse events
时间窗: Up to 48 days
Peak plasma concentration (Cmax)
时间窗: Up to 48 days
The lowest plasma concentration (Cmin)
时间窗: Up to 48 days
Half-life (t1/2)
时间窗: Up to 48 days
Area under the plasma concentration versus time curve (AUC)
时间窗: Up to 48 days
次要结局
- ACR20 score in Patients With Rheumatoid Arthritis(Day 8, 15, 22, 29 and 48 compared to baseline)
- Lymphocyte count(Up to 48 days)
- Percentage of CD3+CD4+ and CD3+CD8+T cells(Up to 48 days)
- Disease Activity Score（DAS28-CRP）in Patients With Rheumatoid Arthritis(Day 8, 15, 22, 29 and 48 compared to baseline)