Un estudio de fase 1 para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de UB-313 en participantes sanos
Un estudio de fase 1 aleatorizado, doble ciego, controlado con placebo, primero en humanos para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de la inmunoterapia UBITh® CGRP (UB-313) en participantes sanos
This first in-human (FIH) study of UB-313, an anti-calcitonin gene-related peptide based immunotherapeutic candidate, is designed to assess the safety, tolerability, and immunogenicity of 4 selected UB-313 dose regimens in healthy adults.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-site, randomized, double-blind, placebo-controlled, multidose regimen, FIH study of UB-313, an anti-CGRP peptide-based immunotherapy candidate. The double-blind period will include dose escalation and cohort staggering for up to 4 planned dose levels of UB-313 or placebo in 4 cohorts of healthy participants. All eligible participants will be enrolled in the study for up to 44 weeks, consisting of IM injections of UB-313 or placebo at Week 0 (Baseline, Day 1), Week 4, and Week 12. The End of Treatment (EoT) is defined as Week 16, followed by a follow-up period up to Week 44.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Leuven, Bélgica
- Katholieke Universiteit Leuven
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Is a male or female aged 18 to 55 years old, inclusive, at time of informed consent.
- Has a body mass index between 18 and 30 kg/m2, inclusive at Screening, and with a minimum weight of 50 kg.
- Male participants and their partners of childbearing potential must commit to the use of highly effective contraceptives for the study duration and for at least 12 weeks after the last dose. Men must refrain from donating sperm during this same period.
- Female participants must be of nonchildbearing potential, or, for women of childbearing potential, must be willing to practice highly effective contraception throughout the duration of the study and for at least 24 weeks following the last dose.
- Other inclusion criteria apply
Exclusion Criteria:
- Has a history of clinically significant medical or psychiatric conditions, which in the opinion of the Investigator may compromise the participant's safety or the scientific value of the study, posing an unacceptable risk to the participant or interfere with the participant's ability to comply with study procedures or abide by study restrictions.
- Presents any concern by the Investigator regarding safe participation in the study or for any other reason (including contraindication to MRI) that the Investigator considers the participant inappropriate for participation in the study.
- Has a recent history (within the past year of Screening) of migraine headache.
- Has unsuitable skin characteristics for the dermal capsaicin challenge as determined by the Investigator.
- Has not demonstrated at least a 100% increase in dermal blood flow following capsaicin challenge as part of Screening procedures and measured through laser speckle contrast imaging.
- Other exclusion criteria apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: UB-313 Cohort 1
UB-313 100mcg administered by intramuscular (IM) injection at Week 0, Week 4 and Week 12 |
A synthetic peptide-based immunotherapy |
|
Experimental: UB-313 Cohort 2
UB-313 300mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12 |
A synthetic peptide-based immunotherapy |
|
Experimental: UB-313 Cohort 3
UB-313 300mcg administered by IM injection at Week 0, Week 4 and Week 12 |
A synthetic peptide-based immunotherapy |
|
Experimental: UB-313 Cohort 4
UB-313 600mcg administered by IM injection at Week 0 and 100mcg at Week 4 and Week 12 |
A synthetic peptide-based immunotherapy |
|
Comparador de placebos: Placebo Comparator
Placebo (normal saline), administered by IM injection at Week 0, Week 4 and Week 12 |
Normal saline |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Periodo de tiempo: 44 weeks
|
The number and percentage of participants with TEAEs were tabulated. |
44 weeks
|
|
Immunogenicity Measured by Serum Anti-CGRP Antibodies.
Periodo de tiempo: Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, 28, 36 and 44; Week 0, Week 16 and Week 44 are reported
|
Immunogenicity measured by blood anti-CGRP antibody titers, reported as Optical Density (OD) of 1:25 dilution. |
Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, 28, 36 and 44; Week 0, Week 16 and Week 44 are reported
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pharmacodynamics of the Immune Response Measured by Capsaicin-induced Increase in Dermal Blood Flow
Periodo de tiempo: Weeks 0, 4, 8, 12, 16, 20
|
Number of Participants with inhibition of capsaicin-induced increase in dermal blood flow |
Weeks 0, 4, 8, 12, 16, 20
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Medical Director, MD, Vaxxinity, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UB-313-101
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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