Healthy VolunteersPhase 1NCT01507402
A Study to Assess the Safety and Tolerability of Single 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 randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy 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
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Nov 2012
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and postmenopausal or surgically sterile females
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive
- 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 or history of significant illness such as, but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
- History of muscle neoplasms such as rhabdomyoma, rhabdomyosarcoma, leiomyoma, leiomyosarcoma or uterine fibroid tumors
- History of muscular dystrophy, myositis, and other primary diseases of skeletal muscle
- History of heart diseases including but not limited to coronary heart disease with/without history of myocardial infarction, chronic or acute heart failure, or cardiac arrhythmia, valvular heart disease or cardiac hypertrophy. Subjects taking prophylactic aspirin are excluded from the study and should not discontinue taking prophylactic aspirin to participate in the study
- History of systemic hypertension or use of concomitant medications to treat hypertension, or history of pulmonary hypertension
- History of diabetes mellitus or gestational diabetes or use of concomitant medications for treatment of these
Show all 17Show fewer
- Recent use of androgenic steroids
- Unexplained creatine phosphokinase (CPK) levels >3X upper limit of normal.
- Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
- Women of childbearing potential (not surgically sterile or amenorrheic for at least twelve months if postmenopausal)
- Onset of a new exercise routine or major change to a previous exercise or diet routine within 4 weeks prior to screening. Subjects must be willing to maintain his/her previous level of exercise for the duration of the study
- Known history of seropositivity to human immunodeficiency virus (HIV) antibody; hepatitis B surface antigen or hepatitis C antibody (HCV) associated with a positive HCV RNA polymerase chain reaction at the screening visit
- Positive urine drug test results during screening or history of drug or alcohol abuse within a year prior to the screening visit
- Any hospitalization within 60 days prior to the screening visit
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
- History of a hypersensitivity reaction to doxycycline or to other tetracycline drugs
- Previous exposure to any biological therapeutic agent, excepting vaccines
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Evansville, Indiana, 47710
Study site
Honolulu, Hawaii
About this study
This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) 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
Administration method A
REGN1033(SAR391786)Drug
Administration method B
PlaceboDrug
(inactive substance)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose regimen 1 (Participants 18 to ≤ 65 yrs old) Receives: Drug: REGN1033(SAR391786); Drug: Placebo |
| Cohort 2 | Experimental | Dose regimen 2 (Participants 18 to ≤ 65 yrs old) Receives: Drug: REGN1033(SAR391786); Drug: Placebo |
| Cohort 3 | Experimental | Dose regimen 3 (Participants 18 to ≤ 65 yrs old) Receives: Drug: REGN1033(SAR391786); Drug: Placebo |
| Cohort 4 | Experimental | Dose regimen 4 (Participants 18 to ≤ 65 yrs old) Receives: Drug: REGN1033(SAR391786); Drug: Placebo |
| Cohort 5 | Experimental | Dose regimen 5 (Participants 18 to ≤ 65 yrs old) Receives: Drug: REGN1033(SAR391786); Drug: Placebo |
| Cohort 6 | Experimental | Dose regimen 6 (Participants 18 to ≤ 65 yrs old) Receives: Drug: REGN1033(SAR391786); Drug: Placebo |
| Cohort 7 | Experimental | Dose regimen 7 (Participants 18 to ≤ 65 yrs old) Receives: Drug: REGN1033(SAR391786); Drug: Placebo |
| Cohort 8 | Experimental | Dose regimen 3 (Participants > 65 to ≤ 85 yrs old) Receives: Drug: REGN1033(SAR391786); Drug: Placebo |
| Cohort 9 | Experimental | Dose regimen 9 (Participants 18 to ≤ 65 yrs old) 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 subjects treated with REGN1033 or placebo, reported from the time of administration of study drug on day 1 (baseline) to completion of the study (day 113).
Measured: Day 1 to Day 113
Secondary outcomes (2)
Serum concentration
To characterize the pharmacokinetic (PK) profile (i.e. serum concentration) of IV and SC doses of REGN1033.
Measured: Baseline to End of Study (Day 113)
Immunogenicity
To assess the potential for immunogenicity following IV and SC doses of REGN1033.
Measured: Baseline to End of Study (Day 113)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionNov 2012
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
- 76 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
- NCT01507402
- Sponsor's protocol ID
- R1033-HV-1107
- Status last verified
- Nov 2012
- First submitted
- 6 Jan 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)
- ClinicalTrials.gov ID
- NCT01507402
- Acronym / sponsor ID
- R1033-HV-1107
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jan 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 randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) 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
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 1 (Participants 18 to ≤ 65 yrs old) |
| Cohort 2 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 2 (Participants 18 to ≤ 65 yrs old) |
| Cohort 3 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 3 (Participants 18 to ≤ 65 yrs old) |
| Cohort 4 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 4 (Participants 18 to ≤ 65 yrs old) |
| Cohort 5 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 5 (Participants 18 to ≤ 65 yrs old) |
| Cohort 6 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 6 (Participants 18 to ≤ 65 yrs old) |
| Cohort 7 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 7 (Participants 18 to ≤ 65 yrs old) |
| Cohort 8 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 3 (Participants > 65 to ≤ 85 yrs old) |
| Cohort 9 | Experimental | Drug: REGN1033(SAR391786), Drug: PlaceboDose regimen 9 (Participants 18 to ≤ 65 yrs old) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males and postmenopausal or surgically sterile females
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive
- 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
Key exclusion criteria (17 listed)
- Significant concomitant illness or history of significant illness such as, but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
- History of muscle neoplasms such as rhabdomyoma, rhabdomyosarcoma, leiomyoma, leiomyosarcoma or uterine fibroid tumors
- History of muscular dystrophy, myositis, and other primary diseases of skeletal muscle
- History of heart diseases including but not limited to coronary heart disease with/without history of myocardial infarction, chronic or acute heart failure, or cardiac arrhythmia, valvular heart disease or cardiac hypertrophy. Subjects taking prophylactic aspirin are excluded from the study and should not discontinue taking prophylactic aspirin to participate in the study
- History of systemic hypertension or use of concomitant medications to treat hypertension, or history of pulmonary hypertension
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)Administration method A | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 8, Cohort 9 |
| REGN1033(SAR391786)Administration method B | Drug | Cohort 5, Cohort 6, Cohort 7 |
| Placebo(inactive substance) | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Number of TEAEs
Time frame: Day 1 to Day 113
The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in subjects treated with REGN1033 or placebo, reported from the time of administration of study drug on day 1 (baseline) to completion of the study (day 113).
2 secondary outcomes
Serum concentration
Time frame: Baseline to End of Study (Day 113)
Immunogenicity
Time frame: Baseline to End of Study (Day 113)
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 14 Nov 2012.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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 4 inclusion and 17 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 14 Nov 2012. 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 113). 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 14 Nov 2012.