A First-in Human, Randomized, Double-blind, Placebo Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
研究概览
简要总结
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects
详细描述
A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects
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
研究组 & 干预措施
Placebo -single dose
Matching placebo administered orally on Day 1
干预措施: Placebo (Drug)
AT-752 250 mg single dose
AT-752 administered orally, 250 mg on Day 1
干预措施: AT-752 (Drug)
AT-752 500 mg single dose
AT-752 administered orally, 500 mg single doses on Day 1 and Day 7
干预措施: AT-752 (Drug)
Placebo- single dose
Matching placebo administered orally on Day 1 and Day 7
干预措施: Placebo (Drug)
AT-752 1000 mg single dose
AT-752 administered orally, 1000 mg single dose on Day 1
干预措施: AT-752 (Drug)
Placebo - single dose
Matching placebo administered orally on Day 1
干预措施: Placebo (Drug)
AT-752 1500 mg single dose
AT-752 administered orally, 1500 mg single dose on Day 1
干预措施: AT-752 (Drug)
Placebo: single dose
Matching placebo administered orally on Day 1
干预措施: Placebo (Drug)
AT-752 - 1000 mg QD multiple doses
AT-752 - administered orally, 1000 mg once daily (QD) for 7 days
干预措施: AT-752 (Drug)
Placebo - Administered once daily (QD)
Matching placebo administered orally once daily (QD) for 7 days
干预措施: Placebo (Drug)
AT-752 - 750 mg twice daily (BID)
AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5.
干预措施: AT-752 (Drug)
Placebo - Administered twice daily (BID)
Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.
干预措施: Placebo (Drug)
AT-752 - 750 mg three times daily (TID)
AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5.
干预措施: AT-752 (Drug)
Placebo - Administered TID
Matching placebo administered orally (TID) for 4 days plus one dose on Day 5.
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
时间窗: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]
Area under the concentration-time curve (AUC)
Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
时间窗: Day 1 for subjects receiving a single fed dose ]
Area under the concentration-time curve (AUC)
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
时间窗: Day 6 for single dose or Day 12 for multiple dose
次要结局
未报告次要终点