None listed
Conditions
Interventions
Drug : 1) Test drug : JBPOS0501 30 mg/ 200 mg capsules
Subjects will be randomly assigned to one of the 30, 90, 200, 400, 800, 1200, or 1600 mg cohorts.
After being admitted on Day -1, placebo or JBP
Sponsors
Bio-Pharm Solutions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, of any race, between 19 and 55 years of age, inclusive. 2. BMI between 19.0 and 32.0 kg/m2, inclusive, with a minimum weight of at least 50.0 kg at the time of screening and on Day -1 (admission date). 3. 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 on the date of admission as assessed by the investigator (or designee). 4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4. 5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion criteria
Exclusion criteria: 1. 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). 2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). 3. 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). 4. Males with QTcF >430 ms and females with QTcF >450 ms on 12-lead ECG performed at screening prior to drug administration (The average result is used by repeating three ECG measurements.) 5. Any of the following: a. QTcF >430 ms (male), QTcF >450 ms (Female) confirmed by calculating the mean of the original value and 2 repeats. b. QRS duration >120 ms confirmed by calculating the mean of the original value and 2 repeats. c. PR interval >220 ms confirmed by calculating the mean of the original value and 2 repeats. d. findings which would make QTc measurements difficult or QTc data uninterpretable. e. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome). 6. Confirmed systolic blood pressure >150 or 90 or 100 or 21 units/week for males and >14 units/week for females. (One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.) 9. Positive urine drug screen at screening or positive alcohol breath test result or positive urine drug screen at screening. 10. Positive hepatitis panel and/or positive rapid plasma reagin test and/or positive human immunodeficiency virus test (Appendix 2). 11. Participation in a clinical study involving administration of an investigational drug, in the past 6 months or 5 half-lives, whichever is longer prior to dosing. 12. Administration of an approved (authorized) Coronavirus Disease 2019 (COVID-19) vaccine in the past 30 days prior to dosing. 13. 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). 14. Use of any medication known to be inhibitors or inducers of CYP1A2, CYP3A4, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 activity within 30 days prior to dosing until the follow up visit. 15. 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). 16. Use or intend to use medications/products considered to still be active within 14 days prior to dosing, unless deemed acceptable by the investigator (or designee). 17. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to date of admission, unless deemed acceptable by the investigator (or designee).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) AE incidence and severity, 2) Vital signs, 3) 12-lead ECG, 4) Physical Examinations, 5) Incidence of abnormalities in clinical laboratory tests based on hematology, blood chemistry, urinalysis, etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics test (Cmax, Tmax, AUC0-tlast, AUC0-inf, t1/2, CL/F, Vz/F, ?z, Ae0-48, Fe0-12, Fe0-48, CLr) | — |
Countries
Korea, Republic of
Contacts
Public ContactJungJin Oh
Seoul National University Hospital
Outcome results
None listed