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

NCT07811999 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 20250008
• Study Type: interventional
• Target: 308
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Participants

Keywords

AMG 785; Healthy Participants; Romosozumab

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab

  Up to Day 85

• Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of romosozumab

  Up to Day 85

• Maximum Observed Serum Concentration (Cmax) of romosozumab

  Up to Day 85

Secondary Outcomes (2)

• Number of Participants Who Experienced Treatment-Emergent Adverse Events and Serious Adverse Events

  Up to Day 85

• Number of Participants Who Developed Anti-romosozumab Antibodies

  Up to Day 85

Study Arms (2)

Romosozumab Test Arm

EXPERIMENTAL

Participants will receive a single SC injection of romosozumab (test) administered using a PFS.

Drug: Romosozumab

Romosozumab Reference Arm

ACTIVE COMPARATOR

Participants will receive two SC injections of romosozumab (reference) administered using a PFS.

Drug: Romosozumab

Interventions

Romosozumab DRUG

Romosozumab will be administered via SC injection using a PFS.

Also known as: AMG 785, Evenity®

Romosozumab Reference Arm; Romosozumab Test Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 from Day 1 through the end of the study.

You may not qualify if:

• Any clinically significant medical condition or abnormal finding that, in the opinion of the study doctor, could make participation unsafe or interfere with the study or its results.
• Clinically significant abnormalities on medical history, physical examination, vital signs, electrocardiogram (ECG), or laboratory tests, including suspected Gilbert syndrome.
• History or current signs or symptoms of significant cardiovascular disease, including heart attack, heart failure, congenital heart disease, cardiomyopathy, valve disease, angina, coronary revascularization, stroke, transient ischemic attack, or peripheral revascularization.
• Clinically significant abnormal heart rhythm or conduction disorder, including clinically significant ECG abnormalities.
• QT interval corrected for heart rate (QTcF) greater than 450 milliseconds for men or greater than 470 milliseconds for women, or a history of long QT syndrome.
• Second- or third-degree atrioventricular (AV) block.
• Systolic blood pressure greater than 140 millimeters of mercury (mmHg) or less than 90 mmHg, diastolic blood pressure greater than 90 mmHg or less than 50 mmHg, or pulse rate greater than 100 beats per minute or less than 40 beats per minute at screening or check-in.
• Deep vein thrombosis or pulmonary embolism within 3 months before screening.
• History of osteoporosis, vertebral fracture, or a fragility fracture of the wrist, upper arm, hip, or pelvis after 50 years of age.
• History of metabolic bone disease, including conditions such as Paget disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, sclerosteosis, ankylosing spondylitis, rheumatoid arthritis, Cushing disease, hyperprolactinemia, or malabsorption syndrome.
• History of osteonecrosis of the jaw.
• Bone fracture within 6 months before screening.
• Vitamin D level below 20 nanograms per milliliter (ng/mL) at screening (participants may be treated and retested before enrollment).
• Current hyperparathyroidism or hypoparathyroidism.
• Kidney function below study requirements (estimated glomerular filtration rate less than 60 mL/min/1.73 m\^2).

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

romosozumab

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: September 22, 2026
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): January 14, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.