A Phase I, First-In-Human, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose Study of TT-00920 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Time of First Occurrence of Cmax （tmax) Time of first Occurance of Cmax（tmax)
研究概览
简要总结
This is a first-in-human, randomized, double-blind, placebo-controlled study. The primary objectives of the study were to investigate the safety and tolerability and determine the PK profiles of single ascending doses (SAD) of TT-00920 administered to healthy subjects. The secondary objectives of the study were to assess the effect of food on the PK of TT-00920 following an oral dose.
详细描述
There will be 4 single-ascending-dose cohorts and 1 cohort for food effect assessment to assess the safety, tolerability, and PK profile. A pilot dose of 20 mg will be evaluated in 2 subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the initiation of dose escalation.
In single-ascending-dose cohorts, 8 subjects per cohort will be enrolled and randomized to assess the safety, tolerability, and PK profile. In food effect cohort, there will be 8 subjects (all receiving TT-00920). Subjects in food effect cohort will receive 2 single dose periods (Fasted/ Fed) in an open-label, crossover design.
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
- Double (Participant, Investigator)
盲法说明
Double (Paticipant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Age ≥ 18 years and ≤ 55 years, male or female of non-childbearing potential (confirmed with follicle stimulating hormone [FSH] test. A bilateral tubal ligation is acceptable as long as there is no fertility potential).
- •Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weighs at least 50 kg.
- •No clinically significant findings in medical examination
排除标准
- •Any history of clinically serious disease.
- •Hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes.
- •Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test
- •Subject with a history of severe visual diseases; or visual changes including flushing lights, blurry vision, color changes, or other visual changes; or abnormal finding with visual tests [color discrimination (Ishihara test) and visual acuity (Snellen chart).
- •Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded.
研究组 & 干预措施
SAD Dose 1
干预措施: TT-00920 (Drug)
Pilot dose Cohort
A pilot dose of 20 mg will be evaluated in 2 subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the initiation of dose escalation.
干预措施: TT-00920 (Drug)
SAD Dose 2
干预措施: TT-00920 (Drug)
SAD Dose 3
干预措施: TT-00920 (Drug)
SAD Dose 4
干预措施: TT-00920 (Drug)
Food Effect Cohort
干预措施: TT-00920 (Drug)
Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Time of First Occurrence of Cmax （tmax) Time of first Occurance of Cmax（tmax)
时间窗: 10 days
PK parameters of TT-00920
Terminal half-life (t1/2)
时间窗: 10 days
PK parameters of TT-00920
Number of participants with Abnormal Laboratory Values
时间窗: 10 days
Safety and tolerability of TT-00920
Area under the plasma drug concentration versus time curve
时间窗: 10 days
PK parameters of TT-00920
Elimination rate (λz)
时间窗: 10 days
PK parameters of TT-00920
Numbers of Treatment Emergent Adverse Events(TEAE)
时间窗: 10 days
Safety and tolerability of TT-00920
Maximum Observed Plasma Concentration (Cmax)
时间窗: 10 days
PK parameters of TT-00920
Clearance (CL/F)
时间窗: 10 days
PK parameters of TT-00920
Volume of distribution (Vz/F)
时间窗: 10 days
PK parameters of TT-00920
次要结局
- Terminal half-life (t1/2)(10 days)
- Elimination rate (λz)(10 days)
- Volume of distribution (Vz/F)(10 days)
- Area under the plasma drug concentration versus time curve(10 days)
- Time of first Occurance of Cmax（tmax)(10 days)
- Clearance (CL/F)(10 days)
- Maximum Observed Plasma Concentration (Cmax)(10 days)