Safety, PK and PD Study in Healthy Male Japanese Subjects

Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sca-136 Administered Orally to Healthy Male Japanese Subjects

Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects

Inclusion Criteria

• Men aged 20 to 45 years at the time of obtaining informed consent.
• Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg.
• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (ADME) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).