NCT07728487招募中1 期
A Phase 1, First-in-Human (FIH), Single-center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of AT-587 in Healthy Adult Participants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
研究概览
简要总结
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy subjects
详细描述
A Phase 1, First-in-Human (FIH), Single-center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of AT-587 in Healthy Adult Participants
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, Care Provider, Investigator)
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
- 是
入选标准
- •Body mass index (BMI) of 18-29 kg/m2
- •Must agree to use protocol-specified methods of contraception
- •Negative pregnancy test
- •Willing to comply with the study requirements and to provide written informed consent
排除标准
- •Pregnant or breastfeeding
- •Abuse of alcohol or drugs
- •Use of other investigational drugs within 30 days of dosing
- •Other clinically significant medical conditions
结局指标
主要结局
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
时间窗: Day 1 up to Day 13
次要结局
- Pharmacokinetics (PK) of AT-587 (Cmax)(Day 1 up to Day 13)
- Pharmacokinetics (PK) of AT-587 (AUC)(Day 1 up to Day 13)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study of BMS-986528 in Participants With Refractory Rheumatoid ArthritisNCT07412704Bristol-Myers Squibb84
招募中
1 期
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate CancerMetastatic Castration-resistant Prostate Cancer (mCRPC)NCT07570979Novartis Pharmaceuticals208
招募中
1 期
First-in-Human Trial of DS1025a in Participants With Advanced Solid TumorsAdvanced Solid TumorMetastatic Solid TumorUnresectable Solid TumorNCT07681882Daiichi Sankyo45
招募中
1 期
A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic DiseasesHealthy Participants StudySjogren's SyndromeRheumatoid ArthritisNCT07712939Candid Therapeutics105
招募中
1 期
Anti-Ly6E Exatecan ADC M7437 in Advanced Solid TumorsNCT07360314EMD Serono Research & Development Institute, Inc.138