Healthy VolunteersPhase 1NCT01910220
Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)
A Phase 1 study testing REGN1033 (SAR391786) in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 5 sites in United States.
Trial summary
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN1033 (SAR391786)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2013to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Athens, Ohio
Study site
Boston, Massachusetts
Study site
Gainesville, Florida
Study site
Orlando, Florida
Study site
St Louis, Missouri
About this study
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- REGN1033 (SAR391786), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN1033 (SAR391786)Drug
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | placebo Receives: Other: placebo |
| Group 2 | Experimental | REGN1033 (SAR391786) Receives: Drug: REGN1033 (SAR391786) |
| Group 3 | Placebo comparator | placebo + exercise regimen Receives: Other: placebo |
| Group 4 | Experimental | REGN1033 (SAR391786) + exercise regimen Receives: Drug: REGN1033 (SAR391786) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total lean mass
The primary endpoint is percent change in total lean mass at week 12 (day 85)
Measured: At week 12
Secondary outcomes (2)
Number of TEAEs
Number of treatment-emergent adverse events (TEAEs) from day 1 (baseline) to day 141 (end of study)
Measured: day 1 to day 141
Appendicular lean mass by DXA
Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910220
- Sponsor's protocol ID
- R1033-HV-1223
- Status last verified
- Nov 2014
- First submitted
- 25 Jul 2013
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)
- ClinicalTrials.gov ID
- NCT01910220
- Acronym / sponsor ID
- R1033-HV-1223
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Other: placeboplacebo |
| Group 2 | Experimental | Drug: REGN1033 (SAR391786)REGN1033 (SAR391786) |
| Group 3 | Placebo comparator | Other: placeboplacebo + exercise regimen |
| Group 4 | Experimental | Drug: REGN1033 (SAR391786)REGN1033 (SAR391786) + exercise regimen |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN1033 (SAR391786) | Drug | Group 2, Group 4 |
| placebo | Other | Group 1, Group 3 |
Primary outcome
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)
2 secondary outcomes
Number of TEAEs
Time frame: day 1 to day 141
Appendicular lean mass by DXA
Time frame: At week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN1033 (SAR391786) in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in total lean mass (time frame: At week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2014.