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OpenTrials
Completed

NCT Number: NCT01910220

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.

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Key information

Conditions

Healthy Volunteers

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
  • Participation in any clinical trial within 6 months prior to screening.
  • Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period.
  • 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.

Treatment and study plan

REGN1033 (SAR391786)

Drug

Placebo

Other

Primary outcomes

  1. Percent change in total lean mass

    Time frame: At week 12

    The primary endpoint is percent change in total lean mass at week 12 (day 85)

Secondary outcomes

  1. Number of TEAEs

    Time frame: day 1 to day 141

    Number of treatment-emergent adverse events (TEAEs) from day 1 (baseline) to day 141 (end of study)

  2. Appendicular lean mass by DXA

    Time frame: At week 12

    Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2013
Registry last updated
Nov 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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