A Single Dose Study of Debio 1450 in Healthy Subjects

Single sentinel dosing of 40 mg per unit capsules is planned to escalate from 80 mg to 160, 320, 480, 640 and 800 mg, per respective dosing group. Doses may be modified based on review of available safety and pharmacokinetic (PK) data.

Matching single sentinel dosing of placebo capsules is planned to escalate from 2 capsules to 4, 8, 12, 16 and 20 capsules, per respective dosing group. The number of capsules will match those delivering Debio 1450 for the group, as those doses may be modified based on review of available safety and pharmacokinetic (PK) data.