Status:
COMPLETED
A Study to Investigate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of HSG4112
Lead Sponsor:
Glaceum
Collaborating Sponsors:
Kyungpook National University Hospital
Seoul National University Hospital
Conditions:
Obesity
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
1. Study Objective \<Part 1\> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in healthy female subjects. \<Part 2\> To...
Eligibility Criteria
Inclusion
- \<Part 1\>
- Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
- Females between 19 and 50 years of age at screening.
- Body mass index (BMI) between 18.0 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 evaluations at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
- Not pregnant or lactating, with a regular menstrual cycle (i.e., 28±7 days).
Exclusion
- 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., 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, aspirin, antibiotics).
- One or more of the following laboratory test results at screening:
- ALT \> 60 IU/L
- Glucose (fasting) \> 100 mg/dL or \< 70 mg/dL
- Systolic blood pressure of \< 90 mmHg or \> 150 mmHg, or diastolic blood pressure of \< 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.
- 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 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 3 months 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.
- 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.
- One or more of the following contraception- or pregnancy-related exclusion criteria:
- Females of childbearing potential who are unable or unwilling to use acceptable contraceptive methods during the study period. 'A female of childbearing potential' refers to premenopausal females (i.e., females who who have experienced amenorrhoea for 12 months or longer) who are capable of becoming pregnant following menarche and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy).
- Acceptable contraceptive methods include: intrauterine device that has been proven highly effective, physical contraception (e.g., diaphragm, uterine cap, condom) used with chemical sterilization (e.g., spermicide), or surgical sterilization (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy) of the subject or the subject's male partner.
- Intend to use hormonal contraceptive methods during the study period.
- Females of childbearing potential who have tested positive for pregnancy, determined by the pregnancy test.
- Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.
- \<Part 2\>
- Inclusion Criteria:
- 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) of 30.0 or higher, with a waist circumference of 90 cm or higher for males and 85 cm or higher for females.
- BMI (kg/m2) = Body weight (kg) / {Height (m)2}
- Deemed acceptable by the Investigator through medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04703764
Start Date
February 15 2021
End Date
February 3 2022
Last Update
September 9 2022
Active Locations (2)
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1
Kyungpook National University Hospital
Daegu, South Korea, 41944
2
Seoul National University Hospital
Seoul, South Korea, 03080