First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders

Single-center, Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Subjects

The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults

Key inclusion Criteria:

• Signed informed consent
• Healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests
• Males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive)
• Women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day -1
• Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive)
• Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 90-140 mmHg, 50-90 mmHg and 50-90 bpm (all inclusive), respectively

Key exclusion Criteria:

• History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment
• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
• Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol