South Rampart Pharma, LLC
This is a two-part randomized, double-blind, placebo-controlled study.
This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).
Inclusion Criteria: 1. Healthy male or female. Females must not be pregnant or breastfeeding. 2. Is between 18 and 55 years of age (inclusive). 3. Able to speak and understand English or Spanish. 4. Agrees to comply with testing procedures. 5. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive). 6. The subject meets good health criteria. 7. Females of non-childbearing potential or agree to use birth control. 8. Male subjects must be surgically sterile or agree to the use birth control. 9. Agree to the confinement period and return for the outpatient visits. 10. Has vital signs…
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
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