This single-site clinical trial is an open-label study to identify the safety and
pharmacokinetics of DPI-386 Nasal Gel (intranasal scopolamine gel) and IV Scopolamine. The
study will require subjects to receive either multiple doses of 0.2 mg or a single dose of
0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, or 1.2 mg of DPI-386 Nasal Gel or 0.4 mg/mL IV Scopolamine
per the assigned treatment cohort. Multiple PK blood draws will be collected dependent on
cohort assignment. Vital signs and ECGs will be collected. No efficacy will be tested.
Subjects will be monitored for at least eight hours after the final dose. There could be up
to 160 subjects enrolled stratified equally by gender.
Screening will not occur until after subjects have signed the informed consent form (ICF).
Screening will include hematology, biochemistry, urinalysis, alcohol and drug screen,
physical examination, including vital signs and ECG, and review of medical history by the PI
or qualified designee, serum pregnancy test as applicable, and agreement to adhere to the
study lifestyle requirements.
Subject data will be recorded in the source documents and appropriate eCRF.