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

Regeneron Pharmaceuticals logo

Regeneron Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: REGN1033 (SAR391786)
Other: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01910220
R1033-HV-1223

Details and patient eligibility

About

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

Enrollment

125 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

125 participants in 4 patient groups, including a placebo group

Group 1
Placebo Comparator group
Description:
placebo
Treatment:
Other: placebo
Group 2
Experimental group
Description:
REGN1033 (SAR391786)
Treatment:
Drug: REGN1033 (SAR391786)
Group 3
Placebo Comparator group
Description:
placebo + exercise regimen
Treatment:
Other: placebo
Group 4
Experimental group
Description:
REGN1033 (SAR391786) + exercise regimen
Treatment:
Drug: REGN1033 (SAR391786)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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