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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: REGN2477
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Clinically significant ECG abnormalities 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 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. History of hypersensitivity reactions to vaccines or other biologics History of hypersensitivity to doxycycline or other tetracycline antibiotics History of osteoporosis requiring osteoporosis treatments such as PTH, bisphosphonates, and denosumab 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 Use of systemic glucocorticoids, including oral glucocorticoids, for more than 10 days, within 3 months prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REGN2477<br>Cohorts 1 - 5 will receive REGN2477 | Drug: REGN2477<br>* Participants will receive ascending doses of REGN2477<br>|
| Experimental: Placebo<br>Cohorts 1 - 5 will receive placebo | Drug: Placebo<br>* Participants will receive matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |