A MAD Study of TT301/MW189 in Healthy Volunteers

Linda Van Eldik

Status and phase

Completed

Phase 1

Conditions

Healthy Adult Volunteers

Treatments

Drug: 0.15mg/kg TT301MW189

Drug: 0.30mg/kg TT301/MW189

Drug: 0.075mg/kg TT301/MW189

Drug: Placebo

Drug: 0.25mg/kg TT301/MW189

Study type

Interventional

Funder types

Other

Identifiers

NCT02942771

TT301/MW189 Phase 1b

Details and patient eligibility

About

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.

Full description

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.

Enrollment

35 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

35 participants in 5 patient groups, including a placebo group

Cohort 1 - TT301/MW189

Experimental group

Description:

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

Treatment:

Drug: 0.075mg/kg TT301/MW189

Cohort 2 -TT301/MW189

Experimental group

Description:

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

Treatment:

Drug: 0.15mg/kg TT301MW189

Cohort 3- TT301/MW189

Experimental group

Description:

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