A Phase 1b, Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TT301/MW189 Administered Intravenously to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this Study is to find out whether an investigational drug is safe and well tolerated. MW189 is being studied as a possible short-term treatment for people with different types of brain injury. MW189 has previously been given to healthy human volunteers as a single dose, and there were no significant problems or bad effects in people who received the Study drug. However, before it can be tested in people with brain injury, it is important to test MW189 in healthy volunteers when given multiple doses.
详细描述
This is a phase 1b study. Written informed consent will be obtained from each study participant before any study-specific procedures or assessments are done.
At various time points noted below, pharmacokinetic (PK) blood sampling will be performed on study participants.
Throughout the study the investigator will be assessing adverse events and concomitant medication.
On-Study/On-Interventions Evaluations/procedures: Participants will arrive at the Phase 1 unit after fasting a minimum of 10 hours, for admission into the unit and will undergo procedures:
- Medical and medication histories
- Infection screen
- Body temperature
- Vital signs (blood pressure and heart rate)
- Physical examination and weight
- Neurological exam
- Safety laboratory tests (blood and urine)
- Urine pregnancy test (females only)
- Alcohol screening (Breathalyzer)
- Urine drug screen
- Hepatitis B, C and HIV screening
- Randomize: Only participants who meet eligibility requirements will be randomized into the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness and capacity to give informed consent
- •Is in good health
- •Weights 50.0 - 120.0 kg
- •Not pregnant
- •Must agree to use birth control for 1 week after the last day of study drug administration
- •Willingness to comply with protocol requirements, including fasting, alcohol and nicotine restrictions, during the study and is available to complete the study
- •Adequate forearm vein access
- •No significant dietary restrictions
- •Must not have donated blood, platelets, or any other blood components 30 days, or plasma 60 days, prior to consenting. Must also agree not to donate blood, platelets, or any other blood components for 8 weeks after the last dose of study drug
排除标准
- •Lactating or is pregnant
- •severe ischemic heart disease or congestive heart failure
- •Heart attack within the previous 2 years;
- •history of stroke or cardiomyopathy;
- •significant liver or kidney disease;
- •diabetes;
- •history of any autoimmune disorder; or a history of chronic infections
- •a history of cancer
- •has received antibiotic treatment or has undergone a surgical procedure within 30 days of Day 1
- •has a history of Hepatitis C, Hepatitis B or tuberculosis (TB)
- •has a history of Human Immunodeficiency Virus (HIV)
- •a history of alcohol or drug use within the twelve months prior to study drug administration
- •has used any immunosuppressants or chronic anti-inflammatory drugs medication including prescription medication, over-the-counter medication, health/herbal supplement or vitamin by any route of administration within 7 days of Day 1
- •has donated blood within 30 days of consenting or has donated plasma within 60 days of consenting
- •has participated in a clinical trial of an immunosuppressive drug within 6 months of Day 1
- •has received an investigational drug, used an investigational device or received an investigational medical procedure within 60 days of Day 1, or concurrent with participation in this study
- •has participated in any observational studies, experimental studies of non-investigational drugs, devices, or medical procedures within 30 days of Day 1, or concurrent with participation in this study
- •has participated in a previous trial with TT301/MW189
- •has a history of unexplained syncope or fainting from the collection of blood; i.e., autonomic dysfunction.
- •Lack of ability to understand verbal and/ or written English
- •had significant trauma or surgical procedure within 1 month prior to Screening.
研究组 & 干预措施
Cohort 1 - TT301/MW189
TT301/MW189 0.075 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
干预措施: 0.075mg/kg TT301/MW189 (Drug)
Cohort 2 -TT301/MW189
TT301/MW189 0.15 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
干预措施: 0.15mg/kg TT301MW189 (Drug)
Cohort 3- TT301/MW189
TT301/MW189 0.25 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
干预措施: 0.25mg/kg TT301/MW189 (Drug)
Cohort 4- TT301/MW189
TT301/MW189 0.30 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
干预措施: 0.30mg/kg TT301/MW189 (Drug)
Placebo
No drug intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-Emergent Adverse Events
时间窗: 4 weeks
The number of participants who experienced treatment-emergent adverse events (TEAEs). A TEAE is defined as an adverse event that started during the treatment period.
Serious Adverse Events
时间窗: 4 weeks
The number of participants who experienced serious adverse events.
次要结局
- Pharmacokinetics - Tmax(5 days)
- Pharmacokinetics - AUC(5 days)
- Pharmacokinetics - T1/2(5 days)
- Pharmacokinetics - Cmax(5 days)
- Pharmacokinetics - Kel(5 days)
研究者
Linda Van Eldik
Sponsor
University of Kentucky