A MAD Study of TT301/MW189 in Healthy Volunteers
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/17/2019 |
| Start Date: | March 20, 2017 |
| End Date: | June 2020 |
| Contact: | Nicholas Eberlein |
| Email: | drcu-recruit@dm.duke.edu |
| Phone: | (919) 613-6244 |
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.
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.
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.
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.
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.
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