A MAD Study of TT301/MW189 in Healthy Volunteers

Phase 1 Completed 35 enrolled Linda Van Eldik Alzheimer's Association · collab Duke Clinical Research Institute · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2017-03-20
Primary completion: 2018-06-04
Completion: 2018-06-04

Publications

Results Van Eldik LJ, Sawaki L, Bowen K, Laskowitz DT, Noveck RJ, Hauser B, Jordan L, Spears TG, Wu H, Watt K, Raja S, Roy SM, Watterson DM, Guptill JT. First-in-Human Studies of MW01-6-189WH, a Brain-Penetrant, Antineuroinflammatory Small-Molecule Drug Candidate: Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Studies in Healthy Adult Volunteers. Clin Pharmacol Drug Dev. 2021 Feb;10(2):131-143. doi: 10.1002/cpdd.795. Epub 2020 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TT301	Small molecule	0.075 mg/kg	Intravenous
Subject	TT301	Small molecule	0.15 mg/kg	Intravenous
Subject	TT301	Small molecule	0.25 mg/kg	Intravenous
Subject	TT301	Small molecule	0.3 mg/kg	Intravenous

Indications

No indication recorded.