Healthy VolunteersPhase 1NCT01720576
Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1033 (SAR391786)
A Phase 1 study testing REGN1033 (SAR391786) in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
This is a study to assess the safety and tolerability of subcutaneously administered 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
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Jun 2013
- 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
- Eligible subjects are males and females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
- A subject must meet the following criteria to be eligible for inclusion in the study:
- Sexually active males willing to use contraceptives during the study and through 4 months after the study.
- Female subjects not of child bearing potential (surgically sterile or postmenopausal for longer than 1 year)
- Body mass index (BMI) between 18.5 and 32 kg/m2 inclusive
- Willing to maintain current diet and exercise routine for the duration of the study
- Willing and able to return for all clinic visits and complete all study-related procedures
- Able to read and understand, and willing to sign the ICF
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.
- Evidence of malnutrition
- Cachexia of any cause
- Evidence or history of muscle diseases or weakness with the exception of age related muscle loss
- Limb amputation
- Immobilization, surgical procedure, fracture, or trauma to the upper or lower limb within 6 months
Show all 22Show fewer
- History or evidence of heart diseases including but not limited to coronary heart disease with/without history of myocardial infarction, chronic or acute heart failure (New York Heart Association [NYHA] stage 2-4), cardiac arrhythmia with clinical symptoms, valvular heart disease, and cardiac hypertrophy of clinical significance
- Women of childbearing potential (not surgically sterile or amenorrheic for at least 12 months if postmenopausal)
- Uncontrolled diabetes defined as HbA1C > 7.5 at screening; if taking oral hypoglycemic drugs, have to be on stable doses of medication for more than 3 months. Diabetics using insulin are excluded
- Asthmatic subjects with current or recurring symptoms within 1 year.
- History of, COPD, chronic kidney disease, cancer except primary basal-cell skin cancer that has been adequately treated
- Neurological injury (eg, stroke) within 1 year
- Abnormal or uncontrolled blood pressure at screening visit defined as diastolic BP >95 and/or systolic BP >160 mm Hg; if taking hypertensive medication, have to be on stable doses of medication for more than 3 months
- Hepatic transaminases (ALT and or AST) > 2X ULN
- Reduced renal function as defined by eGFR<60 mL/min
- Current smokers or previous smokers who stopped smoking within 6 months
- Current or recent history (within 1 year of screen) of alcohol or drug abuse
- History of hypersensitivity response to any biologics
- History of hypersensitivity to doxycycline or other tetracycline antibiotics
- Current or recent participation in any clinical trial (within 30 days of small molecular drugs or within 3 months of biologics)
- Exposure within 3 months to approved biological drugs. (The name of the drug and duration of previous exposure will be recorded). Vaccines are allowed.
- Sexually active men* who are unwilling to practice adequate contraception during the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Daytona Beach, Florida
Study site
Evansville, Indiana
About this study
This is a study to assess the safety and tolerability of subcutaneously administered 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose 1 of REGN1033 (SAR391786) or Placebo Receives: Drug: REGN1033 (SAR391786); Drug: Placebo |
| Cohort 2 | Experimental | Dose 2 of REGN1033 (SAR391786) or Placebo Receives: Drug: REGN1033 (SAR391786); Drug: Placebo |
| Cohort 3 | Experimental | Dose 3 of REGN1033 (SAR391786) or Placebo Receives: Drug: REGN1033 (SAR391786); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of TEAEs
The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in participants treated with REGN1033 (SAR391786) or placebo, reported from the time of administration of study drug on day 1 (baseline) to day 141 (end of study).
Measured: Day 1 to Day 141
Secondary outcomes (2)
Serum concentration of REGN1033 (SAR391786)
Serum concentration of REGN1033 (SAR391786) over time
Measured: Day 1 to Day 141
immunogenicity
Presence or absence of anti-REGN1033 (SAR391786) antibodies over time (immunogenicity )
Measured: Day 1 to Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT01720576
- Sponsor's protocol ID
- R1033-HV-1204
- Status last verified
- Sep 2013
- First submitted
- 29 Oct 2012
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1033 (SAR391786)
- ClinicalTrials.gov ID
- NCT01720576
- Acronym / sponsor ID
- R1033-HV-1204
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Nov 2012 (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 tolerability of subcutaneously administered REGN1033 (SAR391786) in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: REGN1033 (SAR391786), Drug: PlaceboDose 1 of REGN1033 (SAR391786) or Placebo |
| Cohort 2 | Experimental | Drug: REGN1033 (SAR391786), Drug: PlaceboDose 2 of REGN1033 (SAR391786) or Placebo |
| Cohort 3 | Experimental | Drug: REGN1033 (SAR391786), Drug: PlaceboDose 3 of REGN1033 (SAR391786) or Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eligible subjects are males and females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
- Sexually active males willing to use contraceptives during the study and through 4 months after the study.
- Female subjects not of child bearing potential (surgically sterile or postmenopausal for longer than 1 year)
- Body mass index (BMI) between 18.5 and 32 kg/m2 inclusive
- Willing to maintain current diet and exercise routine for the duration of the study
Key exclusion criteria (22 listed)
- Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
- Evidence of malnutrition
- Cachexia of any cause
- Evidence or history of muscle diseases or weakness with the exception of age related muscle loss
- Limb amputation
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 | Cohort 1, Cohort 2, Cohort 3 |
| Placebo | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of TEAEs
Time frame: Day 1 to Day 141
The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in participants treated with REGN1033 (SAR391786) or placebo, reported from the time of administration of study drug on day 1 (baseline) to day 141 (end of study).
2 secondary outcomes
Serum concentration of REGN1033 (SAR391786)
Time frame: Day 1 to Day 141
immunogenicity
Time frame: Day 1 to Day 141
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 12 Sep 2013.
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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
2 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 2 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 8 inclusion and 22 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 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Number of TEAEs (time frame: Day 1 to Day 141). 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 12 Sep 2013.