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

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)