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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910220
• Other study ID #: R1033-HV-1223
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2013
• Last updated: November 7, 2014
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN1033 (SAR391786)

Other:
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in total lean mass	The primary endpoint is percent change in total lean mass at week 12 (day 85)	At week 12	No
Secondary	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	Yes
Secondary	Appendicular lean mass by DXA	Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12	At week 12	No