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

Amgen

Summary

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.

Eligibility

Age range: 18–60 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Healthy adults, male or female, 18 to 60 years of age. * Able and willing to provide written informed consent before any study procedures. * Body weight between 45.0 kg and 95.0 kg (inclusive). * Women must not be able to become pregnant (for example, postmenopausal or permanently sterile, as defined by the protocol). * Men who can father a child must agree to use the required contraception during the study and for 3 months after the study drug dose. * Willing and able to take daily calcium (500 to 2,000 mg elemental calcium) and vitamin D (at least 400 IU) supplements f…

Interventions

Drug
Romosozumab
Romosozumab will be administered via SC injection using a PFS.

Location

QPS Miami
Miami, Florida

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

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