A Phase I Study in Healthy Male and Healthy Female Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MTP-131 (Bendavia™) Using a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design

Stealth BioTherapeutics Inc.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2010年5月最近更新: 2010年11月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Stealth BioTherapeutics Inc.
入组人数: 40
试验地点: 1
主要终点: Treatment emergent adverse events in treatment group versus placebo group

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.

详细描述

The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion. The secondary objective is to evaluate the pharmacokinetics of MTP-131. This is a double-blind, placebo-controlled, randomized trial. A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers. As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers. After the last subject for each cohort has completed the day 3 clinical assessment and no stopping rules have been met according to Safety Review Board decision, the next cohort will commence.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy adult males or females age ≥18 years of age with signed informed consent.
•Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study.

排除标准

•Clinically significant laboratory abnormalities,
•Clinically significant abnormalities on physical examination,
•BMI of less than 18 kg/m2 or greater than 32 kg/m2,
•Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,
•History of seizures or epilepsy,
•History of serious mental illness,
•Participant in unrelated research involving investigational product within 30 days before planned date of drug administration,
•Positive serology for HIV 1, HIV 2, HBsAg, or HCV,
•Fever greater than 37.5°C at the time of planned dosing,
•Suspicion of or recent history of alcohol or substance abuse,
•Donated blood or blood products within the past 30 days,
•Women who are pregnant or breastfeeding,
•Employee or family member of the investigational site, and
•Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products,
•Subjects who are either unwilling to agree to refrain from use or found to be using:
•Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period
•Prescription medications from 14 days prior to and 7 days post treatment
•Oral contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment