At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating 0.075mg/kg TT301/MW189, 0.15mg/kg TT301MW189, and 3 other interventions for Healthy Adult Volunteers. Completed, enrolled 35 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
0.075 mg/kg IV twice daily on Days 1 through 5
0.15 mg/kg IV twice daily on Days 1 through 5
0.25 mg/kg IV twice daily on Days 1 through 5
0.30 mg/kg IV twice daily on Days 1 through 5
0.9% sodium chloride