A phase 1 clinical trial to evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in healthy and obese adult subjects

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0005693
• Lead Sponsor: Glaceum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-03
• Last Update Posted: 20 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
2) Females between 19 and 50 years of age at screening.
3) Body mass index (BMI) between 18.0 and 24.9.
? BMI (kg/m2) = Body weight (kg) / {Height (m)2}
4) In good health, determined by no clinically significant findings from 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.
5) Not pregnant or lactating, with a regular menstrual cycle (i.e., 28±7 days).

1) Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
2) Adults between 19 and 50 years of age at screening.
3) 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}
4) 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.

Exclusion Criteria

1) Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular, psychiatric diseases or 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:
- ALT > 60 IU/L
- Glucose (fasting)
5) 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 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 or bioequivalence study involving administration of an investigational drug, including any study investigating HSG4112, 6 months prior to dosing (i.e., within 6 months of the last dose from the previous study).
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) Smoker. However, participation is acceptable if the subject has quit smoking 3 months prior to dosing.
11) Alcohol consumption of > 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
12) 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.
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) during the admission period.
14) One or more of the following contraception- or pregnancy-related exclusion criteria:
- Females of childbearing potential who are unable or unwilling to use contraceptive methods during the study period. 'A female of childbearing potential' refers to premenopausal females (i.e., females 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 of the subject or the subject's male partner (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy).
- 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.
15) Subject

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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), Volume of Distribution (Vd/F)

Secondary Outcome Measures

Name	Time	Method
Body weight and waist circumference;Leptin, Adiponectin, Insulin, C-peptide, IL-6, TNF-a, CCL2