None listed
Conditions
Interventions
Drug : 1. Single Ascending Dose Study
Out of the 8 subjects in each dose group, 6 subjects will be randomized to the test drug (HGR4113) and 2 subjects will be randomized to placebo. Subjects will rec
Sponsors
Glaceum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to comprehend and willing to sign an informed consent form approved by the IRB before Screening. 2. 19 to 50 years, inclusive, at Screening. 3. BMI =18.0 but <25.0 ? (BMI (kg/m2) = Weight (kg) / Height {(m)}2) 4. In good health, determined by no clinically significant findings from medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluations at Screening, or subjects whose abnormal test results have been deemed acceptable by the Investigator.
Exclusion criteria
Exclusion criteria: 1. Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular, psychiatric diseases (e.g., mood disorder, compulsive disorder). 2. History of stomach or intestinal disorders (e.g., Chrons disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the pharmacokinetic or pharmacodynamic evaluation of the investigational product. 3. Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice, aspirin, antibiotics). 4. One or more of the following laboratory test results at screening: - ANC 150 mmHg, or diastolic blood pressure of 100 mmHg as determined by vital signs monitored after resting in sitting position for 3 minutes or longer. 6. History of drug/chemical abuse or tested positive in urine drug screen. 7. Use or intend to use any prescription medications/products or phytotherapeutic/herbal/plant-derived preparations 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins 7 days prior to dosing, unless deemed acceptable by the Investigator. 8. Participation in any clinical study, including bioequivalence studies, involving administration of an investigational drug 6 months prior to dosing. 9. Whole blood donation within 2 months prior to dosing, plasma/platelet donation within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing. 10. Alcohol consumption of >21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period. 11. History of smoking within 90 days prior to dosing or unable or unwilling to abstain from smoking starting from 90 days prior to dosing until the last pharmacokinetic blood collection timepoint. 12. Ingestion of grapefruit-containing foods or beverages starting from 3 days prior to dosing until the last pharmacokinetic blood collection timepoint or unable to abstain from ingesting such foods or beverages during the same period. 13. Unable to abstain from caffeine-containing foods or beverages (e.g., coffee, tea (black tea, green tea, etc.), soft drinks, coffee milk, energy drinks, sports drinks) starting from 3 days prior to dosing until the last pharmacokinetic blood collection timepoint. 14. Females who have tested positive in a urine HCG test, are pregnant, or lactating before the dosing of an investigational product, excluding females who have experienced amenorrhoea for 12 months or longer or have been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy). 15. Unwilling, or whose partner is unwilling, to use a medically acceptable means of contraception or abstain from sperm donation during the study period and up to 90 days after the last day of dosing. • Medically acceptable means of contraception include: - Use of an intrauterine device that has been proven highly effective by the subject or the subject's partner. - Barrier contraception for males or females used with chemical sterilization - Surgical sterilization of the subject or the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event Monitoring;Physical Examination, Vital Signs, 12-Lead Electrocardiogram, Clinical Laboratory Test;Semen analysis;Maximum Plasma Concentration (Cmax), Area Under the Plasma Concentration-Time Curve from Time Zero to the Last Measurable Point (AUClast), Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf), Time to Maximum Observed Plasma Concentration (tmax), Half-life (t1/2), Oral Clearance (CL/F), Apparent Volume of Distribution (Vz/F);Maximum Plasma Concentration (Cmax), Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau), Area Under the Plasma Concentration-Time Curve from Time Zero to the Last Measurable Point (AUClast), Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf), Minimum Plasma Concentration (Cmin), Time to Maximum Observed Plasma Concentration (tmax), Half-life (t1/2), Oral Clearance (CL/F), Apparent Volume of Distribution (Vz/F) | — |
Secondary
| Measure | Time frame |
|---|---|
| Paraoxonase 1 activity;Paraoxonase 1 activity;Glucose, Hemoglobin A1c, insulin, c-peptide | — |
Countries
Korea, Republic of
Contacts
Public ContactKyung Sang Yu
Seoul National University Hospital
Outcome results
None listed