A MAD Study of TT301/MW189 in 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 ...

Lead sponsor: Linda Van Eldik•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Linda Van Eldik

Collaborators

Duke Clinical Research Institute
Alzheimer's Association

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 16, 2020Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment35

Start dateMar 2017

Last updatedJun 16, 2020

Condition

Healthy Adult Volunteers

Locations shown

Duke Clinical Research Unit 40 Duke Medicine Circle

Durham, North Carolina

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 16, 2020Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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