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Drug Highest PhasePhase 1 |
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MechanismIon channels antagonists |
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Drug Highest PhasePreclinical |
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Drug Highest PhasePending |
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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 (Phase I Part 2) in Healthy Volunteers
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 results from Part 1, healthy volunteers will be administered AFA-281 for 14 consecutive days in 3 cohorts. At scheduled intervals after dosing, and at the end of the cohort's study period to evaluate the safety and tolerability of AFA-281 and the pharmacokinetic profile of AFA-281.
100 Clinical Results associated with AfaSci, Inc.
0 Patents (Medical) associated with AfaSci, Inc.
100 Deals associated with AfaSci, Inc.
100 Translational Medicine associated with AfaSci, Inc.