A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female 19 to 55 years old
- •Willing and able to give informed consent
- •Body Mass Index (BMI) 18 to 30 kg/m2
- •Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
- •Additional inclusion criteria apply
排除标准
- •Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB)
- •Clinically significant abnormalities in baseline results of laboratory evaluations
- •Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- •Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic), or is currently participating in another trial of an investigational drug (or medical device)
- •Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy.
- •Additional exclusion criteria apply
研究组 & 干预措施
TD-1473 for SAD
6 of out 8 subjects per cohort will be randomized to receive TD-1473
干预措施: TD-1473 for SAD (Drug)
Placebo for SAD
2 of out 8 subjects per cohort will be randomized to receive placebo
干预措施: Placebo for SAD (Drug)
TD-1473 for MAD
6 of out 8 subjects per cohort will be randomized to receive TD-1473
干预措施: TD-1473 for MAD (Drug)
Placebo for MAD
2 of out 8 subjects per cohort will be randomized to receive placebo
干预措施: Placebo for MAD (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
时间窗: Day 1 through Day 8 (SAD) or 21 (MAD)
次要结局
- Cmax in plasma, urine and feces(Day 1 through Day 17-19 (MAD))
- Amount excreted in urine (Aeu)(Day 1 through Day 4-6 (SAD))
- Aeu(Day 1 through Day 17-19 (MAD))
- Area under curve (AUC) in plasma, urine and feces(Day 1 through Day 4-6 (SAD))
- AUC in plasma, urine and feces(Day 1 through Day 17-19 (MAD))
- Terminal elimination half-life (t1/2) in plasma, urine and feces(Day 1 through Day 4-6 (SAD))
- Amount excreted in feces (Aef)(Day 1 through Day 4-6 (SAD))
- Aef(Day 1 through Day 17-19 (MAD))
- Tmax in plasma, urine and feces(Day 1 through Day 17-19 (MAD))
- t1/2 in plasma, urine and feces(Day 1 through Day 17-19 (MAD))