Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (COSMIC)
2 de noviembre de 2022 actualizado 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).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
504
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: Study Inquiry
- Número de teléfono: 4156545281
- Correo electrónico: clinicaltrials@vir.bio
Ubicaciones de estudio
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California
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Riverside, California, Estados Unidos, 92503
- Reclutamiento
- Investigative Site
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Florida
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Atlantis, Florida, Estados Unidos, 33462
- Reclutamiento
- Investigative Site
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Edgewater, Florida, Estados Unidos, 32132
- Reclutamiento
- Investigative Site
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Contacto:
- Study Inquiry
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63141
- Reclutamiento
- Investigative Site
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New York
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Binghamton, New York, Estados Unidos, 13901
- Reclutamiento
- Investigative Site
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Oklahoma
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Yukon, Oklahoma, Estados Unidos, 73099
- Reclutamiento
- Investigative Site
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Oregon
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Medford, Oregon, Estados Unidos, 97504
- Reclutamiento
- Investigative Site
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Contacto:
- Study Inquiry
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Texas
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Austin, Texas, Estados Unidos, 78745
- Reclutamiento
- Investigative Site
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Houston, Texas, Estados Unidos, 77065
- Reclutamiento
- Investigative Site
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Utah
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West Jordan, Utah, Estados Unidos, 84088
- Reclutamiento
- Investigative Site
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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 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Part A Cohort 1: Concentration 1 of sotrovimab
administered at injection site 1
|
via IM injection
via IV infusion
|
|
Experimental: Part A Cohort 2: Concentration 2 of sotrovimab
administered at injection site 1
|
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
|
|
Experimental: Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
|
via IM injection
via IV infusion
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
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
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
Periodo de tiempo: Up to Day 29
|
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
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
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
Periodo de tiempo: Up to Week 24
|
Up to Week 24
|
|
Part A: Serum concentration following administration of sotrovimab through Day 29
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part A: Serum concentration following administration of sotrovimab through Week 24
Periodo de tiempo: Up to Week 24
|
Up to Week 24
|
|
Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part A and Part B: Number of participants with AEs, SAEs, and AESI
Periodo de tiempo: Up to Week 35
|
Up to Week 35
|
|
Part B: AUC(D1-29) following administration of sotrovimab
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
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Part B: Cmax following administration of sotrovimab through Day 29
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24
Periodo de tiempo: Up to Week 24
|
Up to Week 24
|
|
Part B: Serum concentration following administration of sotrovimab through Day 29
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part B: Serum concentration following administration of sotrovimab through Week 24
Periodo de tiempo: Up to Week 24
|
Up to Week 24
|
|
Part C: AUC(D1-29) following administration of sotrovimab
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part C: Cmax following administration of sotrovimab through Day 29
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Day 29
Periodo de tiempo: Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Week 24
Periodo de tiempo: Up to Week 24
|
Up to Week 24
|
|
Part C: Number of participants with AEs, SAEs, and AESI
Periodo de tiempo: Up to Week 35
|
Up to Week 35
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
28 de marzo de 2022
Finalización primaria (Anticipado)
4 de marzo de 2024
Finalización del estudio (Anticipado)
30 de mayo de 2024
Fechas de registro del estudio
Enviado por primera vez
4 de marzo de 2022
Primero enviado que cumplió con los criterios de control de calidad
4 de marzo de 2022
Publicado por primera vez (Actual)
15 de marzo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de noviembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
2 de noviembre de 2022
Última verificación
1 de noviembre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VIR-7831-5012
- GSK Study 218128 (Otro identificador: GlaxoSmithKline)
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
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