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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: REGN2477

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477	Day 1 to Day 113

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): January 12, 2017
• Study Completion (Actual): January 12, 2017

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: R2477-HV-1525