AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.

"PART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 \& 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort.~PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 \& 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort.~PART III: A total of 12 healthy male subjects will be randomly assigned to one of two sequences in the crossover study part. All subjects will receive the same dose of AEF0117 which will be determined following the results of the FIH-SAD."

"PART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 \& 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort.~PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 \& 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort."