A Study to Establish Safety and Maximum Tolerated Dose of IV Trehalose in Healthy Subjects

Summary

This will be a double-blind, randomized, placebo-controlled, single ascending dose study performed in healthy subjects. The study will include up to four escalating dose cohorts with eight (8) subjects in each cohort. In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2). All subjects, regardless of their treatment arm assignment, will undergo the same evaluations and will receive the study drug at the clinic. Each subject will continue to be followed for one week post dosing.

Timeline

Start

2016-03

Primary completion

2016-06

Completion

2016-08

Drugs

Indications

No indication recorded.