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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209793
• Other study ID #: R846-HV-1007
• Status: Completed
• Phase: Phase 1
• First received: September 24, 2010
• Last updated: May 31, 2012
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: May 2012
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• REGN846
5 IV cohorts (Dose 1, 2, 3, 4, 5)

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events		Baseline through end of study	Yes
Secondary	PK profile		Baseline through end of study	No
Secondary	Immunogenicity		Visits 2, 8, 10 and 12	No