A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-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
- 20
- 试验地点
- 1
- 主要终点
- Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.
详细描述
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Age ≥ 18.0 years and ≤ 55.0 years, male or female
- •BMI between 18.0 and 30.0 kg/m2, inclusive, and weighs at least 50.0 kg
- •No clinically significant findings in medical examination
排除标准
- •Known hypersensitivity or allergy to lactose
- •Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration
- •Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality
- •HbA1c > 5.7 % at Screening
- •Subject with a history of severe visual diseases; or visual changes
- •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
Dose 1 (Low dose)
TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.
干预措施: TT-00920 (Drug)
Dose 2 (High dose)
TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.
干预措施: TT-00920 (Drug)
Placebo
TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.
干预措施: TT-00920 Placebo (Drug)
结局指标
主要结局
Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]
时间窗: 14 days
* TEAE: Treatment emergent adverse events * Safety parameters: physical examinations, vital signs, clinical laboratory tests , 12-lead ECG in triplicate, cardiac Holter monitoring, visual tests and ophthalmological examinations
次要结局
- Clearance at steady state (CL/F, ss)(14 days)
- Half-life at steady state (T1/2, ss)(14 days)
- Maximum observed plasma concentration at steady state (Cmax, ss)(14 days)
- Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss)(14 days)
- Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)(14 days)
- Minimum observed plasma concentration at steady state (Cmin, ss)(14 days)
- Trough plasma concentration (Ctrough)(14 days)
- Accumulation ratio (Rac)(14 days)
- Average concentration (Cav)(14 days)
- Volume of distribution at steady state (Vz/F, ss)(14 days)