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

NCT01209793 | Completed Phase 1 DMC

• 1 other identifier: R846-HV-1007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Baseline through end of study

Secondary Outcomes (2)

• PK profile

  Baseline through end of study

• Immunogenicity

  Visits 2, 8, 10 and 12

Study Arms (5)

Dose 1

EXPERIMENTAL

(3:1, active: placebo)

Biological: REGN846

Dose 2

EXPERIMENTAL

(3:1, active: placebo)

Biological: REGN846

Dose 3

EXPERIMENTAL

(3:1, active: placebo)

Biological: REGN846

Dose 4

EXPERIMENTAL

(3:1, active: placebo)

Biological: REGN846

Dose 5

EXPERIMENTAL

(3:1, active: placebo)

Biological: REGN846

Interventions

REGN846 BIOLOGICAL

5 IV cohorts (Dose 1, 2, 3, 4, 5)

Dose 1; Dose 2; Dose 3; Dose 4; Dose 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (1)

Nucleus Network

Melbourne, Australia

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

AU (1)