Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects

A Phase 1 Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Healthy Normal Subjects

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of APN1125 when administered as single doses to healthy adult subjects.

The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.

Inclusion Criteria:

• Healthy males and females
• Aged 18 to 65 years, inclusive
• Body mass index (BMI) of 18 to 32kg/m^2 inclusive at Screening
• Non-smoker or no tobacco/nicotine usage with 30 days of Screening

Exclusion Criteria:

• Personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities
• Any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ECG) parameters at Screening and check-in