Single Ascending Dose and Multiple Ascending Dose Study of Voriconazole Inhalation Powder in Healthy Adult Subjects

"PART A (SAD): Voriconazole Inhalation Powder (VIP) will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period.~SAD subjects will receive a single dose of study medication. Subjects in Cohort 1 will receive 10 mg, Cohort 2: 20 mg, Cohort 3: 40 mg, Cohort 4: 80 mg.~PART B (MAD): Voriconazole Inhalation Powder (VIP) and will be administered with a will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period.~MAD subjects will receive VIP BID for a total of 13 doses. Subjects in Cohort 1 will receive 10 mg BID, Cohort 2: 20 mg BID, Cohort 3: 40 mg BID, Cohort 4: 80 mg BID."

"PART A (SAD): Placebo capsules will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period.~Subjects in PART A will receive a single dose of placebo.~PART B (MAD): Placebo will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period.~Subjects in PART B will receive Placebo BID for a total of 13 doses."