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

Part of paid clinical trials in Miami, Florida.

Sponsor
Amgen
Study ID
NCT07811999
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Romosozumab — DRUG
    Romosozumab will be administered via SC injection using a PFS.

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.

Key Dates

First listed
Sep 10, 2026
Start date
Sep 22, 2026
Status verified
Oct 2026
Primary completion
Jan 14, 2027
Completion
Jan 14, 2027

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Romosozumab Test Arm
    Participants will receive a single SC injection of romosozumab (test) administered using a PFS.
  • Active Comparator: Romosozumab Reference Arm
    Participants will receive two SC injections of romosozumab (reference) administered using a PFS.

Primary Outcome Measure

Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab [ Time Frame: Up to Day 85 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
QPS MiamiMiamiFlorida33143-

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By research site
QPS Miami· Miami, FL

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