The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause. This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
28
Administered SC
Administered SC
Covance
Daytona Beach, Florida, United States
Covance Clinical Research Inc
Evansville, Indiana, United States
Covance
Dallas, Texas, United States
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline through Day 85
Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
Time frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B
Time frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B
Time frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
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