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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02870400
First Posted: August 17, 2016
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
August 12, 2016
August 17, 2016
February 20, 2017
July 2016
January 12, 2017   (Final data collection date for primary outcome measure)
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477 [ Time Frame: Day 1 to Day 113 ]
Same as current
Complete list of historical versions of study NCT02870400 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: REGN2477
    Participants will receive ascending doses of REGN2477
  • Drug: Placebo
    Participants will receive matching placebo
  • Experimental: REGN2477
    Cohorts 1 - 5 will receive REGN2477
    Intervention: Drug: REGN2477
  • Experimental: Placebo
    Cohorts 1 - 5 will receive placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
January 12, 2017
January 12, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02870400
R2477-HV-1525
No
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
February 2017

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