A First in Human, Three-part, Double Blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate Safety and Pharmacokinetics of TT5 in Healthy Participants and Surgical Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This study is a First in Human, three-parts, double-blind, randomized, placebo-controlled, single and multiple ascending dose study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 at different doses in healthy and surgical participants.
详细描述
The study will be divided into three parts:
Part A: Single Ascending Dose - healthy participants cohorts with up to 5 dose levels.
Part B: Multiple Ascending Doses - healthy participants cohorts with up to 3 dose levels.
Part C: Surgical patients cohorts with up to 3 dose levels.
The primary Objective is to investigate the safety and tolerability of TT5 in single and multiple ascending intravenous doses in healthy participants and in surgical patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Main inclusion criteria for Parts A and B:
- •Non-smoker for the confinement period of the study.
- •Medically healthy and without clinically significant abnormalities.
- •Negative screen for alcohol and drugs of abuse.
- •No history of psychiatric disorders.
- •Female participants of non-childbearing potential must be post-menopausal or surgically sterile at least 3 months prior to dosing.
- •Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
- •Able to understand the study procedures and provide signed informed consent to participate in the study in English.
排除标准
- •for Parts A and B:
- •History of clinically significant asthma, anaphylaxis, major medical, psychiatric illness or surgery.
- •Acute or chronic clinically relevant systemic disease or disorder.
- •Renal insufficiency
- •History of drug or alcohol consumption abuse.
- •Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine.
- •Have used any investigational drug or participated in any clinical trial within 4 weeks prior to screening.
- •Unable to refrain from strenuous exercise.
- •Participant who has received blood or plasma derivatives, who had a surgery or who has given blood within 4 weeks prior to the screening visit or has planned to give blood or sperm within the 90 days following the study.
- •Pregnant or lactating female participant.
研究组 & 干预措施
TT5 vehicle
干预措施: Placebo - TT5 vehicle (Drug)
TT5
干预措施: TT5 (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs) and serious adverse events (SAEs)
时间窗: SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
Number of AEs and SAEs:To investigate the safety and tolerability of TT5
Clinically significant changes in physical examinations
时间窗: SAD cohorts: Baseline through Day 8; MAD cohorts: Baseline through Day 14
% of participants with clinically significant changes from baseline in physical examinations by measuring general appearance, head, eyes, ears, nose, throat (HEENT), neck (including thyroid and nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, and skin.
Clinically significant changes in vital signs
时间窗: SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
% of participants with clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate
Clinically significant changes in laboratory analysis
时间窗: SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
Mean and SD of clinically significant changes from baseline in laboratory analysis including hematology, coagulation, biochemistry, and urinalysis
Bond and Lader Visual Analog Scale (VAS)
时间窗: SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14
VAS item values: To assess vigilance will using a Visual Analogic Scale namely the Bond-Lader VAS of Mood and Alertness
次要结局
- Plasma Cmax measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Plasma AUC0-t measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Plasma AUC0-inf measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Plasma Tmax measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Plasma T½ el measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Plasma Kel measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Plasma Cl/F measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Plasma Vz/F measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Urine CLr measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Urine Aet1-t2 measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Urine Ae0-t measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- Urine Ae%dose measurement(SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8)
- ARCI(SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14)