Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects

A First-in-Human, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Food Effect of SCB0020160 After Oral Administration in Healthy Adult Male Subjects

This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans.

Healthy adult men aged 18 to 65 years who meet the study eligibility criteria.

Study details

Participants will be randomly assigned to receive either SCB0020160 or placebo. The study includes single-dose and multiple-dose treatment periods, as well as an assessment of the effect of food on the absorption of SCB0020160.

Participants will undergo safety assessments including physical examinations, vital signs, ECGs, blood and urine tests, and monitoring of adverse events. The study will also assess how SCB0020160 is processed by the body.

There is no direct health benefit expected from participation. The results may help determine safe dose levels and support future clinical development of SCB0020160.

This study evaluates the safety, tolerability, and pharmacokinetics of SCB0020160 or placebo following single and multiple oral doses in healthy adult male subjects. A total of 74 subjects were planned, including 64 target subjects (8 per dose group) and 10 substitute subjects. The study may be completed without enrolling substitute subjects if all 64 target subjects complete the study.

Inclusion Criteria:

• Healthy adult male volunteers in the opinion of the principal investigator or delegate, aged 18 to 65 years at screening

• Body weight more Than or equals to 45.0 kilograms per square meter at screening, with a body mass index (BMI) of more than or equals to18.0-kilogram Meter square and less than or equals to 32.0 Kilograms per meter square

  • Body Mass Index (BMI, kilograms per square meter.) = Weight (kilogram)/[Height square meter]

• Eligible to participate in the study based on the results of physical examination, clinical laboratory tests, history taking, and other examinations performed at screening, as determined by the principal investigator or delegate

• Has voluntarily decided to participate and provided written or electronic consent to comply with the precautions after receiving a full explanation of the study and fully understanding it

Exclusion Criteria:

• Has a history of or currently has any disease, including clinically significant hepatobiliary (severe liver impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), neurological, immunological, respiratory, digestive, endocrine, hematologic and oncologic, cardiovascular (Torsades de pointes, etc.), urological, psychiatric (mood disorders, obsessive compulsive disorder, etc.), and sexual function disorders
• Has a history of or currently has a gastrointestinal disease (Crohn's disease, ulcerative colitis, etc.) that may affect the safety and pharmacokinetic evaluation of the investigational product, or has a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery)
• Has a history of hypersensitivity to the active pharmaceutical ingredient and components of the investigational product, drugs in the same class as the active pharmaceutical ingredient, or other drugs (aspirin, antibiotics, etc.)
• Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption
• Has any of the following results in vital signs measured in a sitting position after resting for at least 5 minutes at screening
• Systolic blood pressure more than 80 millimeters of mercury or greater than or equal to140 mmHg
• Diastolic blood pressure less than 45 millimeters of mercury or greater than or equal to140 mmHg 90 millimeters of mercury
• Pulse rate less than 45 beats/min or > 105 beats/min
• Has any of the following results in the 12-lead electrocardiogram measured in a semi-supine position after resting for at least 5 minutes at screening, or has clinically significant rhythm findings
• QTcF less than 450 msec
• Has any of the following results in the screening clinical laboratory tests
• Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI equation) < 90 mL/min/1.73 m²
• Fasting serum glucose more than 5.4 millimoles per liter. or less than 3.0 millimoles per liter.
• AST or ALT 1.5 X the upper limit of normal (ULN)
• Total cholesterol less than 5.5 millimoles per liter
• Triglyceride less than 2.0 millimoles per liter.
• Drinks alcohol persistently (less than 21 units/week, 1 unit = 10 gram = 12.5 milli liter of pure alcohol) or is unable to refrain from alcohol consumption from 3 days prior to the expected first dose of the investigational product until the end of the study
• Tested positive for the breath alcohol test at screening or at check-in on D-1 10) Smokers (However, those who quit smoking 3 months prior to the expected first dose of the investigational product may be eligible as subjects)
• Tested positive for the urine cotinine test at screening or at check-in on D-1, even if they do not smoke
• Has taken any prescribed drugs or herbal medicines within 2 weeks prior to the expected first dose, or has taken any over-the-counter (OTC) drugs, health functional foods including liver supplements, or vitamins within 1 week (However, they may participate in the study if the investigator deems their other conditions appropriate), or is expected to take any of the said agents
• Has taken drugs that induce drug-metabolizing enzymes, such as barbiturates, or drugs that inhibit drug metabolism, such as clarithromycin, within 1 month prior to the expected first dose
• Has a history of alcohol or drug abuse, or has shown a positive result for abused drugs in a urine drug test at screening or at check-in on D-1
• Has participated in another study (including bioequivalence studies) and received an investigational product within 3 months prior to the first dose
• Has donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 1 month prior to the expected first dose
• Has persistently consumed excessive amounts of caffeine (> 5 units/day, 1 unit = 80 mg of caffeine), or is unable to refrain from consuming caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee-flavored milk, health tonics, energy drinks, etc.) from 3 days prior to the expected first dose of the investigational product until the end of the study
• Has consumed grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days prior to the expected first dose of the investigational product until the end of the study, or is unable to refrain from consuming grapefruit-containing foods during this period
• Has unusual eating habits (e.g., consuming more than 1L of grapefruit juice per day) or is unable to consume the standard diet provided by the study site during the inpatient period
• Tested positive for serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
• Subjects who, or whose spouse (or partner) is a woman of childbearing potential, are unable or unwilling to use methods of contraception considered highly effective for the entire period of the study and for at least 90 days after the last dose of the investigational product, and who do not agree to avoid donating sperm/eggs during this period.

[Methods of contraception considered highly effective]

• Intrauterine devices and intrauterine hormone-releasing systems with a proven contraception failure rate (< 1%/year) plus the use of a male condom
• Bilateral tubal occlusion or bilateral tubal ligation plus the use of a male condom
• Azoospermia is confirmed by sperm test after vasectomy
• Hormonal contraception (e.g., combined oral contraceptive, progestogen-only oral contraceptive), contraceptive patch, vaginal ring, injection, subdermal contraceptive implant); however, hormonal contraception is limited to cases where it is being used for 28 days or longer prior to the administration of the investigational product and can be continuously used during the study period and up to 90 days after the last dose plus the use of a male condom.
• Sexual abstinence, if it is the usual and preferred method of contraception.
• Those judged by the principal investigator or delegate to be ineligible for participation in the study for reasons other than the above-mentioned criteria (non-compliance with instructions, etc.)