This is a phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS)
This is a multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS. The study is planned to take place in multiple countries. Subjects who participate in this trial should be treated with standard of care of AIS therapies when appropriate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
Administered by intravenous infusion
Administered by intravenous infusion
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States
The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration.
There were no subjects in either treatment group who met the predefined criteria for the primary safety endpoint: the proportion of subjects with TEAEs judged to be probably or definitely related to the IP within 90 days after the first IP administration.
Time frame: within 90 days after the first IP administration
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