Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects

A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects

A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects

Inclusion Criteria:

• body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
• body weight of 50 to 100 kg, inclusive
• subjects must be in good health

Exclusion Criteria:

• male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
• female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
• history of, any clinically significant major disorder
• clinically significant allergic condition
• significant history of alcoholism or drug/chemical abuse
• use of any tobacco or nicotine-containing products
• clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
• positive urine drugs of abuse screen or alcohol breath test