The primary objective of this trial is to evaluate the relative bioavailability of romosozumab administered as a single 2.34 mL subcutaneous (SC) injection from a prefilled syringe (PFS) or 2 x 1.17 mL SC injections from PFS in healthy participants.
Healthy adults, male or female, 18 to 60 years of age.
Able and willing to provide written informed consent before any study procedures.
Body weight between 45.0 kg and 95.0 kg (inclusive).
Women must not be able to become pregnant (for example, postmenopausal or permanently sterile, as defined by the protocol).
Any clinically significant medical condition or abnormal finding that, in the opinion of the study doctor, could make participation unsafe or interfere with the study or its results.
Clinically significant abnormalities on medical history, physical examination, vital signs, electrocardiogram (ECG), or laboratory tests, including suspected Gilbert syndrome.
History or current signs or symptoms of significant cardiovascular disease, including heart attack, heart failure, congenital heart disease, cardiomyopathy, valve disease, angina, coronary revascularization, stroke, transient ischemic attack, or peripheral revascularization.
Clinically significant abnormal heart rhythm or conduction disorder, including clinically significant ECG abnormalities.
Parallel
Romosozumab
DrugRomosozumab will be administered via SC injection using a PFS.
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of romosozumab
Maximum Observed Serum Concentration (Cmax) of romosozumab
Number of Participants Who Experienced Treatment-Emergent Adverse Events and Serious Adverse Events
Number of Participants Who Developed Anti-romosozumab Antibodies
