A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety and Tolerability of Intravenously Administered REGN846 (SAR302352) in Healthy Volunteers

Regeneron Pharmaceuticals1 个研究点分布在 1 个国家目标入组 40 人2010年11月

适应症Healthy

概览

This study is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.

注册库

clinicaltrials.gov

开始日期

2010年11月

结束日期

2011年9月

最后更新

13年前

研究类型

Interventional

研究设计

Single Group

性别

All

发起方

责任方

Sponsor

•Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
•Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive
•Normal vital signs after resting in a sitting position for 5 minutes:
•Normal standard 12-lead ECG
•Willing and able to comply with clinic visits and study-related procedures
•Provide signed informed consent
•Able to understand and complete study-related questionnaires

•Current or prior history of smoking
•Any illness or condition that would adversely affect the subject's participation in this study
•Hospitalization within 60 days of the screening visit
•Any clinically significant abnormalities observed during the screening visit
•History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
•History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit
•History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit
•Known sensitivity to any of the components of the Investigational Product formulation
•Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
•Any condition that would place the subject at risk, interfere with participation in the study