Study of Orally Administered BEBT-503 in Healthy Subjects

Inclusion criteria

• Males or females, of any race, between 18 and 55 years of age, inclusive.
• Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) with a minimum body weight of 50 kg. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia, eg, suspicion of Gilbert's syndrome based on total and direct bilirubin, is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee), as applicable.
• Resting heart rate ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
• Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day-1) until 90 days after the Follow-up visit.
• Participants have ability to swallow and retain oral medication.
• Able to comprehend and willing to sign an Information and Consent Form and to abide by the study restrictions.

Exclusion criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed, but not cholecystectomy).
• History of malignancy (cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ are eligible).
• Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
• Any of the following:

• corrected QT interval by Fridericia formula> 450 msec confirmed by repeat measurement.
• QRS duration > 120 msec confirmed by repeat measurement.
• PR interval > 220 msec confirmed by repeat measurement.
• findings which would make corrected QT interval measurements difficult or corrected QT interval data uninterpretable.
• history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
• History of alcoholism or drug/chemical abuse within 6 months prior to Check-in.
• Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
• Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in.
• Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test.
• Participation in a clinical study involving administration of an investigational agent or vaccine (new chemical entity) or having received a biological product in the past 90 days prior to dosing.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
• Use of tobacco- or nicotine-containing products within 1 month prior to Check-in, or positive cotinine at Screening or Check-in.
• Receipt of blood products within 2 months prior to Check-in and donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
• Any major surgery within 4 weeks prior to first dosing.
• Poor peripheral venous access.
• Have previously completed or withdrawn from this study investigating BEBT-503, and have previously received the investigational product.
• Subject who, in the opinion of the Investigator (or designee), should not participate in this study.
• Subject is not willing to minimize or avoid exposure to natural or artificial sunlight (tanning beds or ultraviolet A/B treatment) following administration of study drug until 24 hours after the last dose.