A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HGR4113 in Healthy Subjects
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: Able to comprehend and willing to sign an informed consent form approved by the IRB before Screening. Adult volunteers between 19 and 50 years of age at Screening. Body mass index (BMI) between 18.0 and 24.9. ☞ BMI (kg/m^2) = body weight (kg) / (height [m])^2 In good health, determined by no clinically significant findings from medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory tests at Screening, or subjects who are deemed acceptable by the Investigator regardless of the test results. Exclusion Criteria: Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, or cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder). History of stomach or intestinal disorders (e.g., Chron's disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the safety or pharmacokinetic/pharmacodynamic evaluation of the investigational product. Significant history or clinical manifestation of hypersensitivity to any drug including licorice or other drug (e.g., aspirin, antibiotics). One or more of the following laboratory test results at Screening: ANC < 1000 AST, ALT, GGT, total bilirubin > 1.5x upper limit normal Fasting glucose ≥ 126 mg/dL or HbA1c ≥ 6.5% despite two retests eGFR < 60 (CKD-EPI). Systolic blood pressure < 90 mmHg or > 150 mmHg, or diastolic blood pressure < 60 mgHg or > 100 mmHg as determined by vital signs monitored after resting in sitting position for at least 3 minutes. History of drug/chemical abuse or tested positive in urine drug screen. Used or intend to use any prescription medications/products or phytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins within 7 days prior to dosing, unless deemed acceptable by the Investigator. Participation in any clinical study or bioequivalence study within 6 months prior to dosing. 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. Alcohol consumption > 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol 3 days prior to first dosing until the last pharmacokinetic blood sampling. History of smoking within 90 days prior to dosing (however, participation is acceptable if the subject has quit at least 90 days prior to dosing) or unable to abstain from smoking 90 days prior to dosing until the last pharmacokinetic blood sampling. Ingestion of grapefruit-containing foods or beverages 24 hours 3 days prior to dosing until the last pharmacokinetic blood sampling, or unable to abstain from ingesting such foods or beverages during the same period. Unable to abstain from ingesting caffeine-containing foods or beverages (e.g., coffee, tea [e.g., black tea, green tea], soft drinks, coffee milk, energy drinks, sports drinks) 3 days prior to dosing until the last pharmacokinetic blood sampling. Females, excluding those who have amenorrhea for at least 12 months or have been surgically sterilized (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), who are pregnant or lactating, evidenced by a positive urine hCG pregnancy test. Subject or subject's partner is unable or unwilling to use a medically acceptable means of contraception during and for 90 days following the last dosing or willing to donate sperm during the same period. - Acceptable contraceptive methods include: Use of an intrauterine device that has been proven highly effective Male or female physical contraceptive used with chemical sterilization Surgical sterilization of the subject or the subject's partner (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy). Subjects who, in the opinion of the Investigator, should not participate in in this study based on other reasons.
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
HGR4113 300 mg Single Dose
Placebo 300 mg Single Dose
HGR4113 600 mg Single Dose
Placebo 600 mg Single Dose
HGR4113 1200 mg Single Dose
Placebo 1200 mg Single Dose
HGR4113 300 mg Multiple Dose
Placebo 300 mg Multiple Dose
HGR4113 600 mg Multiple Dose
Placebo 600 mg Multiple Dose
HGR4113 1200 mg Multiple Dose
Placebo 1200 mg Multiple Dose
Single oral dosing of HSG4112 300 mg
Single oral dosing of placebo 300 mg
Single oral dosing of HSG4112 600 mg
Single oral dosing of placebo 600 mg
Single oral dosing of HSG4112 1200 mg
Single oral dosing of placebo 1200 mg
Multiple oral dosing of HSG4112 300 mg
Multiple oral dosing of placebo 300 mg
Multiple oral dosing of HSG4112 600 mg
Multiple oral dosing of placebo 600 mg
Multiple oral dosing of HSG4112 1200 mg
Multiple oral dosing of placebo 1200 mg