Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: REGN846

• Registration Number: NCT01209793
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-24
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Study Start: 2010-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area
• Live/attenuated vaccinations within 12 weeks of screening or during the study
• Any subjects with planned elective surgery
• Sexually active men who are unwilling to utilize adequate contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose 4	REGN846	(3:1, active: placebo)
Dose 1	REGN846	(3:1, active: placebo)
Dose 2	REGN846	(3:1, active: placebo)
Dose 3	REGN846	(3:1, active: placebo)
Dose 5	REGN846	(3:1, active: placebo)

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	Baseline through end of study

Secondary Outcome Measures

Name	Time	Method
PK profile	Baseline through end of study
Immunogenicity	Visits 2, 8, 10 and 12

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Melbourne, Australia