Phase 1Recruiting
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
A Phase 1, Open-label, Randomized, Parallel Group Study to Evaluate the Relative Bioavailability of Romosozumab (AMG 785) 210 mg Administered as a Single SC Injection or 2 SC Injections in Healthy Participants
- Sponsor
- Amgen (Industry)
- Enrolment
- 308 planned
- Conditions
- Healthy Participants
- Interventions
- Romosozumab
- Ages
- adults
- Registry
- NCT07811999
From the registry
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.
Primary outcomes
- 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