NCT02942771

A MAD Study of TT301/MW189 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Linda Van Eldik · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
DRUG	0.075mg/kg TT301/MW189	0.075 mg/kg IV twice daily on Days 1 through 5
DRUG	0.15mg/kg TT301MW189	0.15 mg/kg IV twice daily on Days 1 through 5
DRUG	0.25mg/kg TT301/MW189	0.25 mg/kg IV twice daily on Days 1 through 5
DRUG	0.30mg/kg TT301/MW189	0.30 mg/kg IV twice daily on Days 1 through 5
DRUG	Placebo	0.9% sodium chloride

Timeline

• Start date: 2017-03-20
• Primary completion: 2018-06-04
• Completion: 2018-06-04
• First posted: 2016-10-24
• Last updated: 2020-06-16
• Results posted: 2020-06-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study