How the body absorbs romosozumab from one big shot vs two smaller injections
Official title: 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
Run by Amgen · NCT07811999 · Data updated 2026-11-12
This study tests whether a single large subcutaneous injection of romosozumab delivers the same amount of drug in the body as two smaller injections in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 308 (estimated) |
| Sponsor | Amgen Industry-sponsored |
| Drugs / interventions | romosozumab, Denosumab, prednisone |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Status | Recruiting |
| Started | September 22, 2026 |
| Main results expected | January 14, 2027 |
| Study ends | January 14, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07811999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–60 with appropriate weight and stable health conditions who agree to contraception if applicable and to take supplements daily.
✕Probably not a fit
Individuals with significant medical conditions or abnormal baseline tests, or those outside the specified age/weight range, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 trial compares relative bioavailability of romosozumab given as either a single 2.34 mL subcutaneous injection or as two 1.17 mL injections, both from prefilled syringes. Healthy adult participants will receive one of the dosing regimens and will be monitored for safety and how much drug enters systemic circulation. The study does not involve patients with disease and focuses on pharmacokinetic measurements to guide future dosing considerations. Key eligibility includes age 18–60, weight 45–95 kg, and willingness to take calcium and vitamin D supplements during the study.
Why it matters
Potential benefit: If successful, the findings could inform dosing options and administration convenience for romosozumab in future research and clinical use.
How similar studies have gone: Prior pharmacokinetic studies have explored subcutaneous dosing regimens for similar biologics, supporting the feasibility of this approach.
Who can join: the full rules
Show full inclusion / exclusion 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 from Day 1 through the end of the study. Exclusion Criteria: * 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). * Low or high blood calcium levels that do not meet study requirements. * Liver blood test results (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]) above the normal range. * History of hyperthyroidism or hypothyroidism unless on stable treatment for at least 6 months with normal thyroid function tests. * History of hearing loss caused by excessive bone growth compressing the eighth cranial nerve. * Positive test for human immunodeficiency virus (HIV). * Active hepatitis B or hepatitis C infection. * Cancer within the past 5 years, except non-melanoma skin cancer or cervical or breast ductal carcinoma in situ. * History of solid organ or bone marrow transplantation. * History of allergy or hypersensitivity to romosozumab, its ingredients, other biologic medicines, or medicines derived from mammalian cells. * Previous use of medications affecting bone metabolism that are not allowed by the protocol, including: * Any intravenous or oral bisphosphonate. * Fluoride for osteoporosis within 24 months before screening. * Denosumab or cathepsin K inhibitors within 18 months before screening. * Parathyroid hormone or strontium within 12 months before screening. * Calcitonin, selective estrogen receptor modulators, or tibolone within 3 months before screening. * Systemic corticosteroids (5 mg or more prednisone equivalent daily for more than 10 days) within 3 months before screening. * Use of prescription or over-the-counter medications within 30 days or 5 half-lives (whichever is longer) before check-in, unless approved by the study doctor. Acetaminophen up to 2 g/day is permitted. Stable hormone replacement therapy is allowed if unchanged for at least 3 months before dosing and throughout the study. * Use of herbal medicines, vitamins (other than study-required calcium and vitamin D), or dietary supplements within 30 days before enrollment unless approved by the study doctor. * Currently participating in another clinical study, receiving another investigational treatment, or participation in another investigational drug or device study within the previous 90 days or 5 half-lives (whichever is longer). * Previous participation in this study or previous exposure to a sclerostin antibody. * History of alcohol abuse or regular alcohol intake greater than 14 units per week within the year before check-in. * Alcohol use within 48 hours before check-in or unwillingness to comply with study alcohol restrictions. * Positive alcohol test at check-in. * Positive drug screen for illicit drugs, including cannabis, at screening or check-in. * History of illicit drug use within 6 months before screening. * Unwilling to avoid illicit drug use, including cannabis, throughout the study. * Smoking more than 10 cigarettes per day or equivalent nicotine use within 1 month before check-in, or unwillingness to comply with study tobacco restrictions. * Consumption of foods or drinks containing poppy seeds within 7 days before check-in. * Positive pregnancy test at screening or check-in. * Pregnant, breastfeeding, or planning to breastfeed during the study or within 3 months after receiving the study drug. * Receipt of blood products within 2 months before check-in. * Blood donation within 3 months before screening, plasma donation within 2 weeks before screening, or platelet donation within 6 weeks before screening. * Poor veins that would make repeated blood sampling difficult. * Any other reason that, in the opinion of the study doctor, would make participation unsafe or inappropriate.
Where it's running
-
QPS Miami
Miami, Florida, United States Recruiting -
Fortrea Clinical Research Unit Limited - Leeds
Leeds, Lds, United Kingdom Recruiting
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.