Status:
COMPLETED
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HSG4112 in High Doses
Lead Sponsor:
Glaceum
Collaborating Sponsors:
Seoul National University Hospital
Conditions:
Obesity
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
1. Study Objective i) To evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after single and multiple oral administration of high doses in healthy sub...
Eligibility Criteria
Inclusion
- Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
- Adults between 19 and 50 years of age at screening.
- Body mass index (BMI) between 18 and 24.9.
- BMI (kg/m2) = 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 test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
- For Part 2 (i.e., the multiple dose study), female subjects who have regular menstrual cycles(28±7 days) and who are not pregnant or lactating.
Exclusion
- Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder).
- 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.
- Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice-containing drugs, aspirin, antibiotics).
- One or more of the following laboratory test results at screening:
- ALT (SGPT) \> 60 IU/L
- Glucose (fasting) \> 110 mg/dL or \< 70 mg/dL
- Systolic blood pressure of \< 90 mmHg or \> 150 mmHg, or diastolic blood pressure of \< 60 mmHg 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.
- Use 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 involving the administration of an investigational drug, including any study investigating HSG4112, within 6 months prior to dosing (i.e., within 6 months of the last dose from the previous study).
- 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.
- Smoker. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
- Alcohol consumption of \> 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period, starting from 3 days prior to dosing.
- Ingestion of grapefruit-containing foods or beverages 24 hours prior to dosing until discharge, or unable to abstain from ingesting such foods or beverages during the same period.
- Unable to abstain from caffeine-containing foods or beverages (e.g., coffee, tea (e.g., black tea, green tea), soft drinks, coffee milk, energy drinks, sports drinks) during the admission period.
- Unable or unwilling to use acceptable contraceptive methods for themselves or their spouse/partner during the entire study period and up to 28 days after the last dosing and subjects who satisfy at least one of the pregnancy-related criteria below:
- females of childbearing potential who plan to use hormonal contraceptives or oral contraceptives during the study period
- females of childbearing potential confirmed "positive" in a pregnancy test
- "females of childbearing potential" refer to females who have experienced menarche and have not undergone a successful surgical sterilization procedure (i.e., hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy) or is not menopause (i.e., 12 months without menstruation).
- Acceptable contraceptive methods include:
- Use of an intrauterine device, which has been proven highly effective.
- Physical contraception for subject or spouse/partner used with chemical sterilization (e.g., spermicide).
- Surgical sterilization (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy).
- Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05310032
Start Date
April 21 2022
End Date
March 31 2023
Last Update
March 20 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea