- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07811999
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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Amgen Call Center
- Número de telefone: 866-572-6436
- E-mail: medinfo@amgen.com
Locais de estudo
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Florida
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Miami, Florida, Estados Unidos, 33143
- Recrutamento
- QPS Miami
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LDS
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Leeds, LDS, Reino Unido, LS11 9EH
- Recrutamento
- Fortrea Clinical Research Unit Limited - Leeds
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of romosozumab
Prazo: Up to Day 85
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Up to Day 85
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Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of romosozumab
Prazo: Up to Day 85
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Up to Day 85
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Maximum Observed Serum Concentration (Cmax) of romosozumab
Prazo: Up to Day 85
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Up to Day 85
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Number of Participants Who Experienced Treatment-Emergent Adverse Events and Serious Adverse Events
Prazo: Up to Day 85
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Up to Day 85
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Number of Participants Who Developed Anti-romosozumab Antibodies
Prazo: Up to Day 85
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Up to Day 85
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: MD, Amgen
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20250008
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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