Overview

This trial is active, not recruiting.

Condition healthy volunteers
Treatments regn2477, placebo
Phase phase 1
Sponsor Regeneron Pharmaceuticals
Start date July 2016
End date January 2017
Trial size 41 participants
Trial identifier NCT02870400, R2477-HV-1525

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Cohorts 1 - 5 will receive REGN2477
regn2477
Participants will receive ascending doses of REGN2477
(Experimental)
Cohorts 1 - 5 will receive placebo
placebo
Participants will receive matching placebo

Primary Outcomes

Measure
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477
time frame: Day 1 to Day 113

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.