A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)

November 12, 2012 updated by: Regeneron Pharmaceuticals
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Indiana
      • Evansville, Indiana, United States, 47710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy males and postmenopausal or surgically sterile females
  2. Body mass index (BMI) between 18 and 30 kg/m2 inclusive
  3. Willing and able to return for all clinic visits and complete all study-related procedures
  4. Able to read and understand, and willing to sign the ICF

Exclusion Criteria:

  1. 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
  2. History of muscle neoplasms such as rhabdomyoma, rhabdomyosarcoma, leiomyoma, leiomyosarcoma or uterine fibroid tumors
  3. History of muscular dystrophy, myositis, and other primary diseases of skeletal muscle
  4. 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
  5. History of systemic hypertension or use of concomitant medications to treat hypertension, or history of pulmonary hypertension
  6. History of diabetes mellitus or gestational diabetes or use of concomitant medications for treatment of these
  7. Recent use of androgenic steroids
  8. Unexplained creatine phosphokinase (CPK) levels >3X upper limit of normal.
  9. 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
  10. Women of childbearing potential (not surgically sterile or amenorrheic for at least twelve months if postmenopausal)
  11. 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
  12. 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
  13. Positive urine drug test results during screening or history of drug or alcohol abuse within a year prior to the screening visit
  14. Any hospitalization within 60 days prior to the screening visit
  15. 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
  16. History of a hypersensitivity reaction to doxycycline or to other tetracycline drugs
  17. Previous exposure to any biological therapeutic agent, excepting vaccines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cohort 1
Dose regimen 1 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
EXPERIMENTAL: Cohort 2
Dose regimen 2 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
EXPERIMENTAL: Cohort 3
Dose regimen 3 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
EXPERIMENTAL: Cohort 4
Dose regimen 4 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
EXPERIMENTAL: Cohort 5
Dose regimen 5 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
EXPERIMENTAL: Cohort 6
Dose regimen 6 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
EXPERIMENTAL: Cohort 7
Dose regimen 7 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
EXPERIMENTAL: Cohort 8
Dose regimen 3 (Participants > 65 to ≤ 85 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)
EXPERIMENTAL: Cohort 9
Dose regimen 9 (Participants 18 to ≤ 65 yrs old)
Drug: REGN1033(SAR391786)
Administration method A
Drug: REGN1033(SAR391786)
Administration method B
Drug: Placebo
(inactive substance)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day 1 to Day 113

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum concentration
Time Frame: Baseline to End of Study (Day 113)
To characterize the pharmacokinetic (PK) profile (i.e. serum concentration) of IV and SC doses of REGN1033.
Baseline to End of Study (Day 113)
Immunogenicity
Time Frame: Baseline to End of Study (Day 113)
To assess the potential for immunogenicity following IV and SC doses of REGN1033.
Baseline to End of Study (Day 113)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R1033-HV-1107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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