Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy Volunteers

Inclusion Criteria: * Signed and dated informed consent form. * Subjects capable to understand the purposes and risks of the study. * Male volunteers willing to comply with contraception requirements. * Aged 18-60 years, inclusive. * Healthy participants, as determined by screening assessments and Principal Investigator's judgment (absence of active/chronic disease). * Body Mass Index (BMI) of 18-30 kg/m² inclusive. * Male participants with female partners of childbearing potential must agree to be abstinent or use a male condom plus partner use of a contraceptive method. Exclusion Criteria: * Clinically relevant history of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, or connective tissue disorders. * Fridericia's correction factor for QT (QTcF) \> 450 ms or history of QT interval prolongation. * Acute gastrointestinal symptoms at screening/admission. * Any abnormal laboratory value of Grade 2 or higher considered clinically significant. * Values ≥ 10% above upper limit of normal for ALT, AST, Alkaline Phosphatase, Creatinine, or Urea. * Clinically relevant surgical history. * History of relevant drug hypersensitivity, alcoholism, or drug abuse. * Significant infection or known inflammatory process. * Use of prescription/non-prescription medicines within 2 weeks of admission. * Receipt of investigational drug within 30 days prior …