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

The goal of this clinical trial was to learn about the safety and tolerability of an investigational drug called Benfo-oxythiamine (B-OT) in healthy male volunteers. Researchers are studying B-OT to see if it might be used to treat infectious diseases and cancer. This study also looked at how the drug enters, moves through, and leaves the body. The main questions it aimed to answer were: * Is B-OT safe for humans to take? * What medical problems do participants have when taking B-OT? * How much of the drug gets into the blood? Participants: * Took B-OT capsules by mouth either once (single dose group) or once a day for 7 days (multiple dose group). * Stayed in the clinic for several days (4 to 8 nights) for close monitoring. * Gave blood and urine samples for laboratory tests; * Had physical exams, heart rhythm checks (ECG), and vital sign checks (blood pressure, heart rate, breathing rate, and temperature).

Sex

Male

Minimum age

18 Years

Maximum age

60 Years

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 to screening.
* Use of tobacco/nicotine products within 3 months of screening.
* Positive alcohol or drug screen.
* Blood donation within 3 months prior to screening.
* Vaccinated with a Covid-19 vaccine within 2 weeks prior to screening.

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