Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 in Healthy Japanese Male

Inclusion criteria

• Signed the informed consent form as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
• Healthy male 18 to 55 years of age inclusive at the time of signing the informed consent form
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to dosing and throughout the study.
• Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
• Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
• Blood pressure (after supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function.
• Must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after dosing of study treatment and refrain from donating sperm during this period
• Be first generation Japanese.

Exclusion criteria

• Has a history of or current clinically significant medical illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening and Day -1 as deemed appropriate by the investigator
• Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and Day -1 as deemed appropriate by the investigator
• Has donated blood or had a significant blood loss (≤500 mL) within 8 weeks of Day 1 or history of anemia or history of decreased red blood cells (RBC).
• Donated plasma within 7 days of Day -1
• Estimated creatinine clearance <80 mL/min
• Liver function tests (serum alkaline phosphatase [ALP], aspartate transaminase [AST], alanine aminotransferase [ALT]) and serum bilirubin (total and direct) 1.2 times above the upper limit of normal (ULN) at Screening or Day -1.
• Baseline hemoglobin, hematocrit, red blood cell count below the lower limit of normal at Screening and Day -1.
• Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and Day -1.
• Positive cotinine test at Screening and Day -1.
• History of presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.