A Study to Investigate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of HSG4112

  • STATUS
    Recruiting
  • End date
    Aug 3, 2021
  • participants needed
    20
  • sponsor
    Glaceum
Updated on 3 February 2021

Summary

  1. Study Objective:

The objective of this phase 1 clinical trial is to evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in healthy female subjects.

2. Background:

The previous phase 1 clinical trials investigating HSG4112 only included healthy male subjects, and food effect was observed in theses studies - the plasma exposure to HSG4112 following administration under fed conditions was approximately 2.5 times higher compared to the exposure following administration under fasted conditions. This study is designed to evaluate the safety of HSG4112 in healthy female subjects following the administration of HSG4112 under fed conditions.

3. Study Design and Plan:

This study is a dose block-randomized, double-blind, placebo-controlled, multiple dosing, phase 1 clinical study. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. Each subject will be randomized to one of the two dose groups. In each dose group, 8 subjects will be randomized to receive HSG4112 and 2 subjects will be randomized to receive placebo. The subjects will be studied in a double-blind manner will receive the investigational product (i.e., HSG4112 or placebo) via once-daily oral administration for 14 consecutive days. After the post-study visit of the last volunteer in the 480 mg dose group, the Investigator will review all the available safety data in a blinded manner to ensure if it is safe to proceed with the 720 mg dose group. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead electrocardiogram, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.

Details
Condition adiposity, Obesity
Treatment HSG4112, HSG4112 Placebo
Clinical Study IdentifierNCT04703764
SponsorGlaceum
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 19 yrs and 50 yrs?
Are you female?
Do you have any of these conditions: adiposity or Obesity?
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., 287 days)

Exclusion Criteria

Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular, psychiatric diseases or 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 3 minutes or longer
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 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
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)
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 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 (black tea, green tea, etc.), 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 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 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
Subjects who, in the opinion of the Investigator, should not participate in in this study based on clinical laboratory test results or other reasons
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