A MAD Study of TT301/MW189 in Healthy Volunteers
2 de junio de 2020 actualizado por: Linda Van Eldik
A Phase 1b, Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TT301/MW189 Administered Intravenously to Healthy Volunteers
The purpose of this Study is to find out whether an investigational drug is safe and well tolerated.
MW189 is being studied as a possible short-term treatment for people with different types of brain injury.
MW189 has previously been given to healthy human volunteers as a single dose, and there were no significant problems or bad effects in people who received the Study drug.
However, before it can be tested in people with brain injury, it is important to test MW189 in healthy volunteers when given multiple doses.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This is a phase 1b study. Written informed consent will be obtained from each study participant before any study-specific procedures or assessments are done.
At various time points noted below, pharmacokinetic (PK) blood sampling will be performed on study participants.
Throughout the study the investigator will be assessing adverse events and concomitant medication.
On-Study/On-Interventions Evaluations/procedures: Participants will arrive at the Phase 1 unit after fasting a minimum of 10 hours, for admission into the unit and will undergo procedures:
- Medical and medication histories
- Infection screen
- Body temperature
- Vital signs (blood pressure and heart rate)
- Physical examination and weight
- Neurological exam
- Safety laboratory tests (blood and urine)
- Urine pregnancy test (females only)
- Alcohol screening (Breathalyzer)
- Urine drug screen
- Hepatitis B, C and HIV screening
- Randomize: Only participants who meet eligibility requirements will be randomized into the study.
Day 1 - Dosing: A light breakfast will be given prior to dosing. Participants will have the following tests/procedures performed at various time points during the day following confirmation of eligibility.
- 8 electrocardiograms (ECG)
- 8 vital signs (blood pressure and heart rate)
- 1 body temperature
- 12 PK Blood draws
- 2 study drug administrations
Day 2: A light breakfast will be given prior to dosing.
- 8 ECGs
- 8 vital signs (blood pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 2 study Drug administration
Day 3: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given before dosing
- 1 safety laboratory tests (blood and urine)
- 1 ECG
- 2 vital signs (blood pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 1 neurological examination
- 2 study drug administrations
Day 4: A Light breakfast will be given before dosing
- 2 vital signs (blood Pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 2 study drug administrations
Day 5: A Light breakfast will be given before dosing
- 1 ECG
- 2 vital signs (Blood Pressure and heart rate)
- 1 body temperature
- 12 PK blood draw
- 2 study drug administration
Day 6: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given
- 1 safety laboratory test (blood and urine)
- 1 vital sign (Blood pressure and heart rate)
- 1 body temperature
- 1 neurological examination
- 2 PK blood draw
Day 7: A light breakfast will be provided
- 1 vital sign
- 1 body temperature
- 1 PK blood draw
Day 8 (Discharge): Participants will fast for a minimum of 10 hours. Water is allowed. A light breakfast will be offered
- 1 safety laboratory test (blood and urine)
- 1 ECG
- 1 vital sign (blood pressure and heart rate)
- 1 body temperature
- 1 physical examination including weight
1 neurological examination
2 Week Follow-up Visit: Participants will fast for a minimum of 10 hours. Water is allowed.
during this visit participants will have the following tests and procedures performed:
- 1 safety laboratory test (blood and urine)
- 1 ECG
- 1 vital sign (blood pressure and heart rate)
- 1 body temperature
6-8 Week Follow-up Phone Call: Participants will be asked about any adverse events and any medications they may be taking.
Tipo de estudio
Intervencionista
Inscripción (Actual)
35
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.
Ubicaciones de estudio
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27710
- Duke Clinical Research Unit 40 Duke Medicine Circle
-
-
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 50 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Willingness and capacity to give informed consent
- Is in good health
- Weights 50.0 - 120.0 kg
- Not pregnant
- Must agree to use birth control for 1 week after the last day of study drug administration
- Willingness to comply with protocol requirements, including fasting, alcohol and nicotine restrictions, during the study and is available to complete the study
- Adequate forearm vein access
- No significant dietary restrictions
- Must not have donated blood, platelets, or any other blood components 30 days, or plasma 60 days, prior to consenting. Must also agree not to donate blood, platelets, or any other blood components for 8 weeks after the last dose of study drug
Exclusion Criteria:
- Lactating or is pregnant
- severe ischemic heart disease or congestive heart failure
- Heart attack within the previous 2 years;
- history of stroke or cardiomyopathy;
- significant liver or kidney disease;
- diabetes;
- history of any autoimmune disorder; or a history of chronic infections
- a history of cancer
- has received antibiotic treatment or has undergone a surgical procedure within 30 days of Day 1
- has a history of Hepatitis C, Hepatitis B or tuberculosis (TB)
- has a history of Human Immunodeficiency Virus (HIV)
- a history of alcohol or drug use within the twelve months prior to study drug administration
- has used any immunosuppressants or chronic anti-inflammatory drugs medication including prescription medication, over-the-counter medication, health/herbal supplement or vitamin by any route of administration within 7 days of Day 1
- has donated blood within 30 days of consenting or has donated plasma within 60 days of consenting
- has participated in a clinical trial of an immunosuppressive drug within 6 months of Day 1
- has received an investigational drug, used an investigational device or received an investigational medical procedure within 60 days of Day 1, or concurrent with participation in this study
- has participated in any observational studies, experimental studies of non-investigational drugs, devices, or medical procedures within 30 days of Day 1, or concurrent with participation in this study
- has participated in a previous trial with TT301/MW189
- has a history of unexplained syncope or fainting from the collection of blood; i.e., autonomic dysfunction.
- Lack of ability to understand verbal and/ or written English
- had significant trauma or surgical procedure within 1 month prior to Screening.
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cohort 1 - TT301/MW189
TT301/MW189 0.075 mg/kg IV (or matched placebo).
Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
|
0.075 mg/kg IV twice daily on Days 1 through 5
Otros nombres:
|
|
Experimental: Cohort 2 -TT301/MW189
TT301/MW189 0.15 mg/kg IV (or matched placebo).
Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
|
0.15 mg/kg IV twice daily on Days 1 through 5
Otros nombres:
|
|
Experimental: Cohort 3- TT301/MW189
TT301/MW189 0.25 mg/kg IV (or matched placebo).
Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
|
0.25 mg/kg IV twice daily on Days 1 through 5
Otros nombres:
|
|
Experimental: Cohort 4- TT301/MW189
TT301/MW189 0.30 mg/kg IV (or matched placebo).
Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
|
0.30 mg/kg IV twice daily on Days 1 through 5
Otros nombres:
|
|
Comparador de placebos: Placebo
No drug intervention.
|
Cloruro de sodio al 0,9 %
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serious Adverse Events
Periodo de tiempo: 4 weeks
|
The number of participants who experienced serious adverse events.
|
4 weeks
|
|
Treatment-Emergent Adverse Events
Periodo de tiempo: 4 weeks
|
The number of participants who experienced treatment-emergent adverse events (TEAEs).
A TEAE is defined as an adverse event that started during the treatment period.
|
4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pharmacokinetics - Cmax
Periodo de tiempo: 5 days
|
Maximum observed concentration in plasma.
|
5 days
|
|
Pharmacokinetics - Tmax
Periodo de tiempo: 5 days
|
Time to maximum concentration
|
5 days
|
|
Pharmacokinetics - AUC
Periodo de tiempo: 5 days
|
Area under the concentration-time curve
|
5 days
|
|
Pharmacokinetics - T1/2
Periodo de tiempo: 5 days
|
Terminal half-life (T1/2)
|
5 days
|
|
Pharmacokinetics - Kel
Periodo de tiempo: 5 days
|
Elimination rate constant
|
5 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Linda J. Van Eldik, PhD, University of Kentucky
- Investigador principal: Jeffrey T. Guptill, MD, MA,MHS, Duke University
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)
20 de marzo de 2017
Finalización primaria (Actual)
4 de junio de 2018
Finalización del estudio (Actual)
4 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
20 de octubre de 2016
Primero enviado que cumplió con los criterios de control de calidad
21 de octubre de 2016
Publicado por primera vez (Estimar)
24 de octubre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
2 de junio de 2020
Última verificación
1 de junio de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- TT301/MW189 Phase 1b
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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
producto fabricado y exportado desde los EE. UU.
No
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