Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (COSMIC)
2 de novembro de 2022 atualizado por: Vir Biotechnology, Inc.
A Phase 1, Open-label, Randomized, Parallel Group, Single-dose Clinical Pharmacology Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Different Concentrations of Sotrovimab Administered at Different Injection Sites, in Male or Female Healthy Participants Aged 18 to 65 Years
This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy participants aged 18 to 65 years.
The study will be conducted in three parts (Part A, an optional Part B and Part C).
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
504
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Study Inquiry
- Número de telefone: 4156545281
- E-mail: clinicaltrials@vir.bio
Locais de estudo
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California
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Riverside, California, Estados Unidos, 92503
- Recrutamento
- Investigative Site
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Florida
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Atlantis, Florida, Estados Unidos, 33462
- Recrutamento
- Investigative Site
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Edgewater, Florida, Estados Unidos, 32132
- Recrutamento
- Investigative Site
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Contato:
- Study Inquiry
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63141
- Recrutamento
- Investigative Site
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New York
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Binghamton, New York, Estados Unidos, 13901
- Recrutamento
- Investigative Site
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Oklahoma
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Yukon, Oklahoma, Estados Unidos, 73099
- Recrutamento
- Investigative Site
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Oregon
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Medford, Oregon, Estados Unidos, 97504
- Recrutamento
- Investigative Site
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Contato:
- Study Inquiry
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Texas
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Austin, Texas, Estados Unidos, 78745
- Recrutamento
- Investigative Site
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Houston, Texas, Estados Unidos, 77065
- Recrutamento
- Investigative Site
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Utah
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West Jordan, Utah, Estados Unidos, 84088
- Recrutamento
- Investigative Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Male or female participants, aged 18 to 65 years, inclusive.
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- For Part C, inclusion in the Japanese subgroup analysis, a participant must meet all of the following criteria: Japanese ancestry, defined as being a descendant of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents.
- Body Mass Index (BMI) within the range of 18 to 30 kilogram per square meter (kg/m^2).
- Capable of giving signed informed consent
Exclusion Criteria:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Breast cancer within the past 10 years
- Abnormal blood pressure at Screening.
- Known hypersensitivity to any constituent present in the investigational product or history of severe hypersensitivity or anaphylaxis after receiving a COVID-19 vaccine
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Use of any over the counter or prescription medications unless permitted by the protocol or approved by the Investigator in conjunction with the GSK medical monitor.
- For Part A and Part B, any condition that would prohibit receipt of injections in the investigator's opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia.
- Treatment with biologic agents (such as) within 3 months or 5 half-lives
- Receipt of convalescent plasma from a recovered COVID-19 participant or anti- severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) monoclonal antibody (mAb) within the last 3 months.
- Receipt of any vaccine within 48 hours prior to enrollment.
- Has received a SARS-CoV-2 vaccine but has not completed all doses in the series more than 28 days prior to Screening.
- Exposure to more than 4 new chemical entities (e.g., investigational pharmaceuticals) within 12 months prior to the first dosing day.
- Enrolment in any investigational vaccine study within the last 180 days or enrollment in any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives
- Current enrolment or past participation in this clinical study.
- A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to dosing.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- History of regular alcohol consumption within 6 months prior to the study.
- Regular use of known drugs of abuse.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Part A Cohort 1: Concentration 1 of sotrovimab
administered at injection site 1
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via IM injection
via IV infusion
|
|
Experimental: Part A Cohort 2: Concentration 2 of sotrovimab
administered at injection site 1
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via IM injection
via IV infusion
|
|
Experimental: Part A Cohort 3: Concentration 2 of sotrovimab
administered at injection site 2
|
via IM injection
via IV infusion
|
|
Experimental: Part A Cohort 4: Concentration 2 of sotrovimab
administered at injection site 3
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via IM injection
via IV infusion
|
|
Experimental: Part B Cohort 5: Concentration 1 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
Experimental: Part B Cohort 6: Concentration 2 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
Experimental: Part C Cohort 7: Concentration 2 of sotrovimab
administered by intravenous (IV) infusion
|
via IM injection
via IV infusion
|
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Experimental: Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
|
via IM injection
via IV infusion
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Part A (Cohort 1, 2): Area under the serum concentration-time curve (AUC) from Day 1 to Day 29 (AUC D1-29) following administration of sotrovimab
Prazo: Up to Day 29
|
Up to Day 29
|
|
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
Prazo: Up to Day 29
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Up to Day 29
|
|
Part A (Cohort 1, 2): Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI) through Day 29
Prazo: Up to Day 29
|
Up to Day 29
|
|
Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI
Prazo: Up to Day 29
|
Up to Day 29
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
Prazo: Up to Day 29
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Up to Day 29
|
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Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29
Prazo: Up to Day 29
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Up to Day 29
|
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Part A (Cohort 1, 2, 3, 4): Area under the serum concentration-time curve from time zero to infinity (AUCinf) following administration of sotrovimab at injection sites 1, 2 and 3 through Week 24
Prazo: Up to Week 24
|
Up to Week 24
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Part A: Serum concentration following administration of sotrovimab through Day 29
Prazo: Up to Day 29
|
Up to Day 29
|
|
Part A: Serum concentration following administration of sotrovimab through Week 24
Prazo: Up to Week 24
|
Up to Week 24
|
|
Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI
Prazo: Up to Day 29
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Up to Day 29
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Part A and Part B: Number of participants with AEs, SAEs, and AESI
Prazo: Up to Week 35
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Up to Week 35
|
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Part B: AUC(D1-29) following administration of sotrovimab
Prazo: Up to Day 29
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Up to Day 29
|
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Part B: Cmax following administration of sotrovimab through Day 29
Prazo: Up to Day 29
|
Up to Day 29
|
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Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24
Prazo: Up to Week 24
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Up to Week 24
|
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Part B: Serum concentration following administration of sotrovimab through Day 29
Prazo: Up to Day 29
|
Up to Day 29
|
|
Part B: Serum concentration following administration of sotrovimab through Week 24
Prazo: Up to Week 24
|
Up to Week 24
|
|
Part C: AUC(D1-29) following administration of sotrovimab
Prazo: Up to Day 29
|
Up to Day 29
|
|
Part C: Cmax following administration of sotrovimab through Day 29
Prazo: Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Day 29
Prazo: Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Week 24
Prazo: Up to Week 24
|
Up to Week 24
|
|
Part C: Number of participants with AEs, SAEs, and AESI
Prazo: Up to Week 35
|
Up to Week 35
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de março de 2022
Conclusão Primária (Antecipado)
4 de março de 2024
Conclusão do estudo (Antecipado)
30 de maio de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
4 de março de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de março de 2022
Primeira postagem (Real)
15 de março de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de novembro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de novembro de 2022
Última verificação
1 de novembro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VIR-7831-5012
- GSK Study 218128 (Outro identificador: GlaxoSmithKline)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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