Scopolamine in Healthy Volunteers

Inclusion Criteria

• •1. Provision of signed and dated ICF.
• •2. Stated willingness to comply with all study procedures and availability for the duration of the study.
• •3. Male or female, aged 18 to 40 (inclusive).
• •4. Males and females must agree to use highly effective contraception (e.g. double barrier method) for 4 weeks after receiving the last dose of treatment.
• •5. Have a body mass index (BMI) within a range of 18 to 30 inclusive.
• •6. In good general health as evidenced by medical history with no recent history or current diagnosis of significant cardiovascular or respiratory problems as assessed by the PI or qualified designee.
• •7. Hematology, biochemistry, urinalysis and drug and alcohol laboratory test results that are determined by the PI or qualified designee to be not clinically significant.
• •8. Ability to take intranasal medication (for Cohorts 1-4, and 6-15 only) and willingness to adhere to the study schedule and time constraints.
• •9. For females of child-bearing potential: willingness to provide a sample for the pregnancy test upon every visit. Test must be negative.
• •Note: Women of non-childbearing potential are defined as those who are non-surgically sterile (i.e., without menses for at least 12 consecutive months) or surgically sterile (i.e., those who underwent a hysterectomy with or without oophorectomy, fallopian tube ligation, and endometrial ablation).
• •10. Agreement to adhere to the following lifestyle compliance considerations:
• •1. Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the treatment day.
• •2. Caffeine intake limited to 300 mg on treatment day (two 8-ounce cups).
• •3. Abstain from alcohol for 24 hours prior to first dose of study medication.
• •4. Refrain from any type of nicotine within 30 days prior to the screening visit and through the completion of the treatment day.