NCT01910220

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

July 25, 2013

Last Update Submit

November 7, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Percent change in total lean mass

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

    At week 12

Secondary Outcomes (2)

  • Number of TEAEs

    day 1 to day 141

  • Appendicular lean mass by DXA

    At week 12

Study Arms (4)

Group 1

PLACEBO COMPARATOR

placebo

Other: placebo

Group 2

EXPERIMENTAL

REGN1033 (SAR391786)

Drug: REGN1033 (SAR391786)

Group 3

PLACEBO COMPARATOR

placebo + exercise regimen

Other: placebo

Group 4

EXPERIMENTAL

REGN1033 (SAR391786) + exercise regimen

Drug: REGN1033 (SAR391786)

Interventions

REGN1033 (SAR391786)DRUG
Group 2Group 4
placeboOTHER
Group 1Group 3

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Gainesville, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Athens, Ohio, United States

Location

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 29, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2014

Study Completion

October 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

US(5)