Scopolamine in Healthy Volunteers

The investigational product is a combination product comprised of: (a) a vial prefilled with DPI-386 Nasal Gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. For Cohorts 1 through 4, 9 through 10,13, and 14 each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the active ingredient along with the excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride, polyvinyl alcohol and purified water. For Cohorts 1 through 4, 9, 10 and 13 through 16 each vial of DPI-386 Nasal Gel is a multi-dose product, sufficient for six individual doses. Each pumping action is designed to deliver a single 0.12 g dose. The DPI-386 Nasal Gel for Cohorts 1 through 4, 13 and 14 is formulated to contain 0.2 mg scopolamine HBr per 0.12 g dose, with each dose therefore described as "0.2 mg / 0.12 g". For Cohort 6 the dose is "0.8 mg / 0.12 g", and for cohort 7 the dose is "1.0 mg / 0.12 g", and for Cohort 8 the dose is "1.2 mg / 0.12 g", and for Cohort 11 the dose is "0.4 mg / 0.12 g", and for Cohort 12 and 15 the dose is "0.6 mg / 0.12 g", delivered in a single dose, and for Cohort 16 the dose is "0.6 mg / 0.12 g", in a modified excipient formulation, delivered in a single dose. For Cohort 16 only: Each 0.12 gram of the gel contains 0.6 mg of scopolamine HBr as the active ingredient along with a modified formulation of excipients sodium citrate, citric acid, sodium metabisulfite, glycerin, benzalkonium chloride 100, polyvinyl alcohol 18, and purified water. Each vial/pump unit must be primed by research staff prior to first dose delivery. Subjects will self-administer the drug under guidance from the study staff.