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First received: September 12, 2022

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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