Healthy Volunteer Subjects Clinical Trial
Official title:
A Single Center, Single Ascending Dose, Double-Blind, Randomized, Placebo-Controlled Trial to Establish Safety and the Maximum Tolerated Dose of Intravenous Trehalose Solution in Healthy Subjects
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.
This is 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.
Cohorts 1 to 3 After all subjects in a given cohort complete their 1-week follow-up visit
(Visit 4), a Safety Review Committee (SRC) will review the safety and PK data of that cohort.
If no safety concerns are identified, and the exposure data supports a higher dose is
acceptable, the SRC will approve continuation into the next cohort (dose level).
Cohort 4 Cohort 4 will be initiated based on review of the safety and exposure data from the
first 3 cohorts by the SRC. This cohort will only be performed if there is a suggestion that
exposure can be safely increased.
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