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CompletedNCT04732988Updated Nov 1, 2021

A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112

A Phase 1 interventional study of HSG4112 and Placebo in Obesity, sponsored by Glaceum. Completed at 2 sites in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.

Sponsored by Glaceum · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Aug 2018, registered Jan 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

  1. Study Objective: The objective of this phase 1 clinical trial is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect of HSG4112 after oral administration in healthy male subjects.
  2. Study Design and Plan: This study is a dose-block randomized, double-blind, placebo-controlled, single and multiple dosing, dose-escalation phase 1 clinical trial. 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 six groups for the single ascending dose (SAD) study or one of the three groups for the multiple ascending dose (MAD) study. Each dose group will consist of ten subjects, and among the ten subjects, eight subjects will be randomized to receive HSG4112 and two subjects will be randomized to receive placebo. The subjects will be studied in a double-blind manner and will receive the investigational product (i.e., HSG4112 or placebo) via once-daily oral administration. The dosing duration for the MAD study is 14 days. When escalating the dose, the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead electrocardiogram, laboratory test, semen analysis (MAD study only), physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.
02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Glaceum is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

  3. Body mass index (BMI) between 18 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 electrocardiogram, and clinical laboratory test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  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 of more of the following laboratory test results at screening:

    • ALT (SGPT) > 60 IU/L
    • Glucose (fasting) > 110 mg/dL or \< 70 mg/dL
    • Testosterone \<2.49 ng/mL or > 8.36 ng/mL
  5. 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.
  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 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.
  8. 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).
  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, or receipt of blood products within 1 month prior to dosing.
  10. Alcohol consumption of > 20 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
  11. Smoked within 90 days prior to dosing. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
  12. Smoker. However, participation is acceptable if the subject has quit smoking at least 3 months prior to dosing.
  13. 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.
  14. 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.

  15. Unable or unwilling to use acceptable contraceptive methods during the study period.

    ☞ Acceptable contraceptive methods include:

    • Use of an intrauterine device, which has been proven highly effective, by the subject's spouse/partner.
    • Physical contraception for subject or spouse/partner used with chemical sterilization.
    • Surgical sterilization (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy) of the subject or the subject's spouse/partner.
  16. Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    HSG4112 30 mg Single Dose

    Single oral dosing of HSG4112 30 mg

    Drug: HSG4112

  • Placebo comparator
    Placebo 30 mg Single Dose

    Single oral dosing of Placebo 30 mg

    Drug: Placebo

  • Experimental
    HSG4112 60 mg Single Dose

    Single oral dosing of HSG4112 60 mg

    Drug: HSG4112

  • Placebo comparator
    Placebo 60 mg Single Dose

    Single oral dosing of Placebo 60 mg

    Drug: Placebo

  • Experimental
    HSG4112 120 mg Single Dose

    Single oral dosing of HSG4112 120 mg

    Drug: HSG4112

  • Placebo comparator
    Placebo 120 mg Single Dose

    Single oral dosing of Placebo 120 mg

    Drug: Placebo

  • Experimental
    HSG4112 240 mg Single Dose (Fasted)

    Single oral dosing of HSG4112 240 mg under fasted conditions

    Drug: HSG4112

  • Experimental
    HSG4112 240 mg Single Dose (Fed)

    Single oral dosing of HSG4112 240 mg under fed conditions

    Drug: HSG4112

  • Placebo comparator
    Placebo 240 mg Single Dose

    Single oral dosing of Placebo 240 mg

    Drug: Placebo

  • Experimental
    HSG4112 480 mg Single Dose

    Single oral dosing of HSG4112 480 mg

    Drug: HSG4112

  • Placebo comparator
    Placebo 480 mg Single Dose

    Single oral dosing of Placebo 480 mg

    Drug: Placebo

  • Experimental
    HSG4112 720 mg Single Dose

    Single oral dosing of HSG4112 720 mg

    Drug: HSG4112

  • Placebo comparator
    Placebo 720 mg Single Dose

    Single oral dosing of Placebo 720 mg

    Drug: Placebo

  • Experimental
    HSG4112 240 mg Multiple Dose

    Once-daily multiple oral dosing of HSG4112 240 mg for 14 days

    Drug: HSG4112

  • Placebo comparator
    Placebo 240 mg Multiple Dose

    Once-daily multiple oral dosing of Placebo 240 mg for 14 days

    Drug: Placebo

  • Experimental
    HSG4112 480 mg Multiple Dose

    Once-daily multiple oral dosing of HSG4112 480 mg for 14 days

    Drug: HSG4112

  • Placebo comparator
    Placebo 480 mg Multiple Dose

    Once-daily multiple oral dosing of Placebo 480 mg for 14 days

    Drug: Placebo

Interventions

  • DrugHSG4112

    Once-daily oral administration

    Also known as: 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol

  • DrugPlacebo

    Once-daily oral administration

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval

    Area under the plasma concentration-time curve of HSG4112 over dosing interval (AUCtau)

    Time frame: Hour 0 to 24

  2. Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point

    Area under the plasma concentration-time curve from time zero to the last measurable point (AUClast)

    Time frame: Hour 0 to 192

  3. Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity

    Area under the plasma concentration-time curve from time zero to infinity (AUCinf)

    Time frame: Hour 0 to 192

  4. Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112

    Maximum plasma concentration of HSG4112 (Cmax)

    Time frame: Hour 0 to 192

  5. Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112

    Time to maximum observed plasma concentration of HSG4112 (Tmax)

    Time frame: Hour 0 to 192

  6. Pharmacokinetic Assessment by Half-Life of HSG4112

    Half-life of HSG4112 (T1/2)

    Time frame: Hour 0 to 192

  7. Pharmacokinetic Assessment by Oral Clearance of HSG4112

    Oral clearance of HSG4112 (CL/F)

    Time frame: Hour 0 to 192

  8. Pharmacokinetic Assessment by Volume of Distribution of HSG4112

    Volume of distribution of HSG4112 (Vd/F)

    Time frame: Hour 0 to 192

  9. Safety and Tolerability Assessment by Adverse Event Monitoring

    Number of participants with observed adverse events

    Time frame: Up to 12 weeks from day of last dosing

  10. Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs

    Number of participants with clinically significant change in vital signs including blood pressure (mmHg) measured with blood pressure monitor, heart rate (beats per minute) measured with pulse oximeter, and body temperature (degrees Celcius) measured with thermometer

    Time frame: Up to 3 weeks from day of last dosing

  11. Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram

    Number of participants with clinically significant change in 12-lead electrocardiogram

    Time frame: Up to 3 weeks from day of last dosing

  12. Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test

    Number of participants with clinically significant change in laboratory test assessed through hematology, blood biochemistry, urinalysis, and blood coagulation test

    Time frame: Up to 3 weeks from day of last dosing

  13. Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination

    Number of participants with clinically significant change in physical examination

    Time frame: Up to 3 weeks from day of last dosing

  14. Safety and Tolerability Assessment by Number of Patients with Change in Semen Volume

    Pre-to-post examination of semen volume (milliliters) by semen analysis to assess the safety and tolerability of HSG4112

    Time frame: Up to 12 weeks from day of last dosing

  15. Safety and Tolerability Assessment by Number of Patients with Change in Semen pH

    Pre-to-post examination of semen white blood cells (10\^3 per microliter) by semen analysis to assess the safety and tolerability of HSG4112

    Time frame: Up to 12 weeks from day of last dosing

  16. Safety and Tolerability Assessment by Number of Patients with Change in Semen White Blood Cells

    Pre-to-post examination of semen white blood cells (10\^3 per microliter) by semen analysis to assess the safety and tolerability of HSG4112

    Time frame: Up to 12 weeks from day of last dosing

  17. Safety and Tolerability Assessment by Number of Patients with Change in Sperm Count

    Pre-to-post examination of sperm count (10\^6 per milliliter) by semen analysis to assess the safety and tolerability of HSG4112

    Time frame: Up to 12 weeks from day of last dosing

  18. Safety and Tolerability Assessment by Number of Patients with Change in Sperm Motility

    Pre-to-post examination of sperm motility (percent of sperm with normal motility) by semen analysis to assess the safety and tolerability of HSG4112

    Time frame: Up to 12 weeks from day of last dosing

  19. Safety and Tolerability Assessment by Number of Patients with Change in Sperm Morphology

    Pre-to-post examination of sperm morphology (percent of normal sperm) by semen analysis to assess the safety and tolerability of HSG4112

    Time frame: Up to 12 weeks from day of last dosing

Secondary outcomes

  1. Pharmacodynamic Assessment by Change of Biomarkers

    Measurement of biomarkers including leptin, adiponectin, insulin, C-peptide (connecting peptide), IL6 (interleukin 6), TNF-alpha (tumor necrosis factor alpha), and CCL2 (C-C motif ligand 2) from baseline to day of last dosing will be combined to assess the weight loss effect of HSG4112

    Time frame: Day 1 and 14 pre-dose

07

Study locations

2 sites
  • Kyungpook National University Hospital
    Daegu, 41944, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04732988
Lead sponsor
Glaceum
Collaborators
Seoul National University Hospital, Kyungpook National University Hospital
Responsible party
Sponsor
First posted
Feb 1, 2021
Start date
Aug 23, 2018
Primary completion
May 24, 2021
Completion
May 24, 2021
Last update
Nov 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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