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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

12 de octubre de 2026 actualizado por: Amgen

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

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.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

308

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Amgen Call Center
  • Número de teléfono: 866-572-6436
  • Correo electrónico: medinfo@amgen.com

Ubicaciones de estudio

    • Florida
      • Miami, Florida, Estados Unidos, 33143
        • Reclutamiento
        • QPS Miami
    • LDS
      • Leeds, LDS, Reino Unido, LS11 9EH
        • Reclutamiento
        • Fortrea Clinical Research Unit Limited - Leeds

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Romosozumab Test Arm

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

Romosozumab will be administered via SC injection using a PFS.

Otros nombres:
  • AMG 785
  • Evenity®
Comparador activo: Romosozumab Reference Arm

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

Romosozumab will be administered via SC injection using a PFS.

Otros nombres:
  • AMG 785
  • Evenity®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab
Periodo de tiempo: Up to Day 85
Up to Day 85
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of romosozumab
Periodo de tiempo: Up to Day 85
Up to Day 85
Maximum Observed Serum Concentration (Cmax) of romosozumab
Periodo de tiempo: Up to Day 85
Up to Day 85

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Number of Participants Who Experienced Treatment-Emergent Adverse Events and Serious Adverse Events
Periodo de tiempo: Up to Day 85
Up to Day 85
Number of Participants Who Developed Anti-romosozumab Antibodies
Periodo de tiempo: Up to Day 85
Up to Day 85

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: MD, Amgen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de septiembre de 2026

Finalización primaria (Estimado)

14 de enero de 2027

Finalización del estudio (Estimado)

14 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

4 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20250008

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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