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

Sponsor ID
20250008
Clinicaltrials.gov ID
NCT07811999
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 785
Type
Interventional
Masking
None (Open Label)
Enrollment
308
Additional Study Details

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

Location
Status
Contact Us
Location
QPS Miami
Miami, Florida, United States, 33143
Status
Recruiting
Location
Fortrea Clinical Research Unit Limited - Leeds
Leeds, LDS, United Kingdom, LS11 9EH
Status
Recruiting