Clinical Trial: Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults
Study Status: Completed
Recruit Status: RECRUITING
Condition: Acute Ischemic Stroke
Study Type: INTERVENTIONAL
Official Title: A Single-Center, Randomized, Placebo-Controlled, Single Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Nts-104 Tris in Healthy Adults
Brief Summary:
NTS-104 TRIS will be administered as a single intravenous dose to healthy subjects at doses of 0.8, 4, 8 and 16 mg/kg in 4 Cohorts.Each cohort of 8 subjects will begin with dosing 2 sentinel subjects with one being given the investigational product and one the placebo.If no safety issues arise, dosing the remaining subjects in the cohort will begin.A Safety Review Committee will review the safety and pharmacokinetic data before approving escalation to the next dose level.
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