NCT05409924已完成1 期
The ATTRACTIVE 1 Trial - a First-in-human Phase I, Dose Escalating, Double-blind, Placebo-controlled, Single and Multiple Dose Trial of ATR-258 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Atrogi AB
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Safety analyses after multiple doses of ATR-258
研究概览
简要总结
This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 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
Phase B
Experimental
ATR-258 Multiple Ascending Dose or placebo
干预措施: ATR-258 (Drug)
Phase A
Experimental
ATR-258 Single Ascending Dose or placebo
干预措施: ATR-258 (Drug)
Phase C
Experimental
ATR-258 Repeated dosing or placebo
干预措施: ATR-258 (Drug)
结局指标
主要结局
Safety analyses after multiple doses of ATR-258
时间窗: maximum 56 days post dosing
Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258
Safety analyses after single dose of ATR-258
时间窗: maximum 7 days post dosing
Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258
次要结局
- PK analyses will be performed after PK of ATR-258 multiple dose(maximum 56 days post dosing)
- PK analyses will be performed after PK of ATR-258 single dose(maximum 7 days post dosing)
研究者
研究点 (1)
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