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

Bioblast Pharma Ltd. · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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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.
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