Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)

This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: placebo; Drug: REGN1033 (SAR391786)

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States
    • Orlando, Florida, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Missouri
    • St. Louis, Missouri, United States
  • Ohio
    • Athens, Ohio, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and postmenopausal females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
2. Low activity lifestyle
3. Diet and exercise adherence

Exclusion Criteria:

1. Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
2. Participation in any clinical trial within 6 months prior to screening.
3. Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period.
4. Limb amputation (except for toes) and/or any fracture within 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1; placebo	Other: placebo
Experimental: Group 2; REGN1033 (SAR391786)	Drug: REGN1033 (SAR391786)
Placebo Comparator: Group 3; placebo + exercise regimen	Other: placebo
Experimental: Group 4; REGN1033 (SAR391786) + exercise regimen	Drug: REGN1033 (SAR391786)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in total lean mass	The primary endpoint is percent change in total lean mass at week 12 (day 85)	At week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of TEAEs	Number of treatment-emergent adverse events (TEAEs) from day 1 (baseline) to day 141 (end of study)	day 1 to day 141
Appendicular lean mass by DXA	Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12	At week 12

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Estimate): November 10, 2014
• Last Update Submitted That Met QC Criteria: November 7, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: R1033-HV-1223