A Phase I, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose and Multiple 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
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects.
详细描述
This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will comprise of 10 randomized subjects. Subjects received a single dose of TT-00920/ placebo during a single dose period, followed by a 3-10 day washout period, and then entered a 7-day multiple dose period, in which subjects received TT-00920/ placebo three times daily (TID) for days 1-6 and a single dose on day 7. 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
- Sequential
- 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 male weighs at least 50.0 kg and female weighs at least 45.0 kg
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
- •Subject with a history of severe visual diseases; or visual changes
- •Subject is unable to complete this study for other reasons
研究组 & 干预措施
Dose 1
low dose
干预措施: TT-00920 (Drug)
Dose 2
Middle dose
干预措施: TT-00920 (Drug)
Dose 3
High dose
干预措施: TT-00920 (Drug)
Placebo
干预措施: TT-00920 Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator
时间窗: 20 days
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Percentage of Participants With Clinically relevant changes in vital signs
时间窗: 20 days
Vital signs include temperature, respiratory rate, blood pressure and pulse
Percentage of Participants With Clinically relevant changes in clinical laboratory tests
时间窗: 20 days
Safety laboratory tests includes hematology, coagulation, serum chemistries, and urinalysis.
Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG)
时间窗: 20 days
A standard 12-lead ECG was performed.
次要结局
- Derived single dose PK parameters(20 days)
- Derived multiple dose PK parameters(20 days)