A MAD Study of TT301/MW189 in Healthy Volunteers
2 juin 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
35
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
North Carolina
-
Durham, North Carolina, États-Unis, 27710
- Duke Clinical Research Unit 40 Duke Medicine Circle
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 50 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
|
Expérimental: 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
Autres noms:
|
|
Expérimental: 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
Autres noms:
|
|
Expérimental: 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
Autres noms:
|
|
Comparateur placebo: Placebo
No drug intervention.
|
0,9 % de chlorure de sodium
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serious Adverse Events
Délai: 4 weeks
|
The number of participants who experienced serious adverse events.
|
4 weeks
|
|
Treatment-Emergent Adverse Events
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pharmacokinetics - Cmax
Délai: 5 days
|
Maximum observed concentration in plasma.
|
5 days
|
|
Pharmacokinetics - Tmax
Délai: 5 days
|
Time to maximum concentration
|
5 days
|
|
Pharmacokinetics - AUC
Délai: 5 days
|
Area under the concentration-time curve
|
5 days
|
|
Pharmacokinetics - T1/2
Délai: 5 days
|
Terminal half-life (T1/2)
|
5 days
|
|
Pharmacokinetics - Kel
Délai: 5 days
|
Elimination rate constant
|
5 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Linda J. Van Eldik, PhD, University of Kentucky
- Chercheur principal: Jeffrey T. Guptill, MD, MA,MHS, Duke University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 mars 2017
Achèvement primaire (Réel)
4 juin 2018
Achèvement de l'étude (Réel)
4 juin 2018
Dates d'inscription aux études
Première soumission
20 octobre 2016
Première soumission répondant aux critères de contrôle qualité
21 octobre 2016
Première publication (Estimation)
24 octobre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juin 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juin 2020
Dernière vérification
1 juin 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- TT301/MW189 Phase 1b
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .