A Phase 1 interventional study of Romosozumab in Healthy Participants, sponsored by Amgen. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Amgen · Phase 1, Interventional, and Basic science
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.
Exclusion Criteria:
Participants will receive a single SC injection of romosozumab (test) administered using a PFS.
Drug: Romosozumab
Participants will receive two SC injections of romosozumab (reference) administered using a PFS.
Drug: Romosozumab
Romosozumab will be administered via SC injection using a PFS.
Also known as: AMG 785, Evenity®
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab
Time frame: Up to Day 85
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of romosozumab
Time frame: Up to Day 85
Maximum Observed Serum Concentration (Cmax) of romosozumab
Time frame: Up to Day 85
Number of Participants Who Experienced Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: Up to Day 85
Number of Participants Who Developed Anti-romosozumab Antibodies
Time frame: Up to Day 85
No study locations are listed for this record.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Amgen