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

Regeneron Pharmaceuticals0 sites41 target enrollmentJuly 2016

ConditionsHealthy Volunteers

InterventionsPlacebo REGN2477

DrugsREGN2477 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy Volunteers
Sponsor: Regeneron Pharmaceuticals
Enrollment: 41
Primary Endpoint: Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

January 12, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Significant illness or history of significant illness
•Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening
•Current smoker or former smoker who has stopped smoking within 3 months prior to screening
•Positive urine drug test results during screening, or history of drug or alcohol abuse
•Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening
•History of diabetes
•Abnormal blood pressure (BP)
•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
•Reduced renal function
•Known history of chronic hepatitis or HIV

Arms & Interventions

Placebo

Cohorts 1 - 5 will receive placebo

Intervention: Placebo

REGN2477

Cohorts 1 - 5 will receive REGN2477

Intervention: REGN2477

Outcomes

Primary Outcomes

Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477

Time Frame: Day 1 to Day 113

Secondary Outcomes

Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time(Day 1 to Day 113)
Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time(Day 1 to Day 113)