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First received: September 14, 2022

Clinical Trial: Phase I Single Ascending Dose and Multiple Ascending Doses of Oral AFA-281 in Healthy Volunteers

Study Status: Completed

Recruit Status: RECRUITING

Condition: Pain, Neuropathic

Study Type: INTERVENTIONAL


Official Title: A Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Oral AFA-281 (Phase I Part 1) and Multiple Ascending Doses of Oral AFA-281 (Pha

Brief Summary: Phase I Part 1 (single ascending dose):Double-blind dosing will occur in healthy volunteers in 5 cohorts of 8 subjects each.Six subjects in each cohort will be randomized to receive AFA-281 and 2 subjects will be randomized to receive the matching placebo.At the end of the Part 1 study is to evaluate the safety and tolerability of AFA-281.Following completion of each cohort, bioanalytical analyses will be conducted to evaluate the pharmacokinetic profile.Phase I Part 2 (multiple dose for 14 days):Pending the…

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