Will Be Recruiting
Sponsor ID
20250008
Comparing the Extent to Which Romosozumab (AMG 785) is Made Available in the Body When Administered as a Single SC Injection or as 2 SC Injections
Study Details
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.
Protocol Summary
Primary Outcome Measures
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab
Timeframe: Up to Day 85
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of romosozumab
Timeframe: Up to Day 85
Maximum Observed Serum Concentration (Cmax) of romosozumab
Timeframe: Up to Day 85
Secondary Outcome Measures
Number of Participants Who Experienced Treatment-Emergent Adverse Events and Serious Adverse Events
Timeframe: Up to Day 85
Number of Participants Who Developed Anti-romosozumab Antibodies
Timeframe: Up to Day 85
Locations
No locations found.