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

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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: REGN2477 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : July 2016
Actual Primary Completion Date : January 12, 2017
Actual Study Completion Date : January 12, 2017

Arm Intervention/treatment
Experimental: REGN2477
Cohorts 1 - 5 will receive REGN2477
Drug: REGN2477
Participants will receive ascending doses of REGN2477

Experimental: Placebo
Cohorts 1 - 5 will receive placebo
Drug: Placebo
Participants will receive matching placebo

Primary Outcome Measures :
  1. Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477 [ Time Frame: Day 1 to Day 113 ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time [ Time Frame: Day 1 to Day 113 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02870400

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Antwerp, Belgium
Sponsors and Collaborators
Regeneron Pharmaceuticals
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals Identifier: NCT02870400    
Other Study ID Numbers: R2477-HV-1525
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017