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A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477

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ClinicalTrials.gov Identifier: NCT02870400
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 12, 2016
First Posted Date  ICMJE August 17, 2016
Last Update Posted Date February 20, 2017
Study Start Date  ICMJE July 2016
Actual Primary Completion Date January 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477 [ Time Frame: Day 1 to Day 113 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02870400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time [ Time Frame: Day 1 to Day 113 ]
  • Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time [ Time Frame: Day 1 to Day 113 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Intravenously and Subcutaneously Administered REGN2477 in Healthy Women Not of Childbearing Potential
Brief Summary The primary objective of the study is to assess the safety and tolerability of single ascending doses of REGN2477 in healthy women not of childbearing potential.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: REGN2477
    Participants will receive ascending doses of REGN2477
  • Drug: Placebo
    Participants will receive matching placebo
Study Arms  ICMJE
  • Experimental: REGN2477
    Cohorts 1 - 5 will receive REGN2477
    Intervention: Drug: REGN2477
  • Experimental: Placebo
    Cohorts 1 - 5 will receive placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2016)
41
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
40
Actual Study Completion Date  ICMJE January 12, 2017
Actual Primary Completion Date January 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy women not of childbearing potential between 18 and 65 years of age, with no significant health issues or clinically significant abnormal laboratory findings
  2. A body mass index (BMI) between 18 to 30 kg/m2, inclusive
  3. Provide a signed informed consent

Exclusion Criteria:

  1. Significant illness or history of significant illness
  2. Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening
  3. Current smoker or former smoker who has stopped smoking within 3 months prior to screening
  4. Positive urine drug test results during screening, or history of drug or alcohol abuse
  5. Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening
  6. History of diabetes
  7. Abnormal blood pressure (BP)
  8. History of gynecological disorders or malignancies; history of breast malignancies; or history of benign gynecological or breast lesions that require medical treatment or follow up
  9. Reduced renal function
  10. Known history of chronic hepatitis or HIV
  11. Clinically significant ECG abnormalities
  12. Participation in any clinical research study within 30 days, or 5 halflives, of the study drug, whichever is greater, or for longer periods per regional requirements, prior to the screening visit
  13. Exposure to any biological drugs within 3 months of the screening visit (the name of the drug and duration of previous exposure will be recorded). Vaccination within 4 weeks of screening visit.
  14. History of hypersensitivity reactions to vaccines or other biologics
  15. History of hypersensitivity to doxycycline or other tetracycline antibiotics
  16. History of osteoporosis requiring osteoporosis treatments such as PTH, bisphosphonates, and denosumab
  17. Subject using hormone replacement therapy or thyroid replacement therapy will be excluded, unless they have been on stable doses of such therapy for at least 6 months and will remain on the same stable dose through the duration of the trial
  18. Use of systemic glucocorticoids, including oral glucocorticoids, for more than 10 days, within 3 months prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02870400
Other Study ID Numbers  ICMJE R2477-HV-1525
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP