Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects

Exclusion Criteria

• •1. Clinically significant cardiovascular or cerebrovascular event or new diagnosis within 6 months of screening.
• •2. Clinically significant medical history or clinical manifestation of any significant metabolic, allergic, hepatic, renal, hematological, pulmonary, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator).
• •3. History of malignancy, except resected, localized basal cell carcinoma, and squamous cell carcinoma.
• •4. Abnormal, clinically significant electrocardiogram findings, in the opinion of the investigator.
• •5. Abnormal, clinically significant liver function laboratory test results at screening as determined by the investigator.
• •6. Calculated creatinine clearance (Cockcroft-Gault) \< 90 mL/min at screening.
• •7. Positive for hepatitis B surface antigen (HbsAg), human immunodeficiency antibodies (antiHIV), or hepatitis C virus antibodies (antiHCV) plus HCV-RNA. Subjects who are antiHCV positive, but HCV-RNA negative (secondary to treatment or viral clearance) are eligible with at least a 1-year period since documented sustained viral response at Week 12 post-treatment.
• •8. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to study entry.
• •9. Any acute or chronic condition that, in the opinion of the investigator, would limit the subject's ability to complete and/or participate in this clinical study.