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

NCT ID: NCT01910220

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Group 2

REGN1033 (SAR391786)

Group Type EXPERIMENTAL

REGN1033 (SAR391786)

Intervention Type DRUG

Group 3

placebo + exercise regimen

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Group 4

REGN1033 (SAR391786) + exercise regimen

Group Type EXPERIMENTAL

REGN1033 (SAR391786)

Intervention Type DRUG

Interventions

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REGN1033 (SAR391786)

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Gainesville, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Boston, Massachusetts, United States

Site Status

St Louis, Missouri, United States

Site Status

Athens, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R1033-HV-1223

Identifier Type: -

Identifier Source: org_study_id