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

NCT04703764 | Completed Phase 1

• 1 other identifier: HSG4112-P1-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.Study Objective
2. 2.Background
3. 3.Study Design and Plan

Conditions

Obesity

Outcome Measures

Primary Outcomes (13)

• 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,ss)

  Hour 0 to 24

• 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)

  Hour 0 to 192

• 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)

  Hour 0 to 192

• Pharmacokinetic Assessment by Maximum and Minimum Plasma Concentration of HSG4112

  Maximum and minimum plasma concentration of HSG4112 (Cmax,ss; Cmin,ss)

  Hour 0 to 192

• Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112

  Time to maximum observed plasma concentration of HSG4112 (Tmax)

  Hour 0 to 192

• Pharmacokinetic Assessment by Half-Life of HSG4112

  Half-life of HSG4112 (T1/2)

  Hour 0 to 192

• Pharmacokinetic Assessment by Oral Clearance of HSG4112

  Oral clearance of HSG4112 (CLss/F)

  Hour 0 to 192

• Pharmacokinetic Assessment by Volume of Distribution of HSG4112

  Volume of distribution of HSG4112 (Vd/F)

  Hour 0 to 192

• 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

  Day 1, 14, and post-study visit

• 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

  Day -1, 11, and post-study visit

• 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

  Day -1, 8, 13, 15, 17, and post-study visit

• Safety and Tolerability Assessment by Pregnancy Test

  Monitoring the pregnancy status of participants through urine pregnancy test by measuring the level of human chorionic gonadotropin

  Day -1, 11, and post-study visit

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

  Number of participants with clinically significant change in physical examination

  Day -1, 1 to 14, 17, and post-study visit

Secondary Outcomes (5)

• Pharmacodynamic Assessment by Change of Body Weight in Healthy Subjects

  Day -1, 8, 15, and 22

• Pharmacodynamic Assessment by Change of Body Weight in Obese Subjects

  Day 1 to 17, 18, 20, and 22

• Pharmacodynamic Assessment by Change of Waist Circumference

  Day -1, 8, 15, and 22

• Pharmacodynamic Assessment by Change of Biomarkers

  Day 1 and 14 pre-dose

• Pharmacodynamic Assessment by Change of Fat Mass and Body Fat Percentage

  Day 1, 8, 15, and 22

Study Arms (4)

HSG4112 480 mg

EXPERIMENTAL

60 mg HSG4112 tablet, 8 tablets, once-daily, 14-day multiple oral administration

Drug: HSG4112

Placebo 480 mg

PLACEBO COMPARATOR

60 mg placebo tablet, 8 tablets, once-daily, 14-day multiple oral administration

Drug: Placebo

HSG4112 720 mg

EXPERIMENTAL

60 mg HSG4112 tablet, 12 tablets, once-daily, 14-day multiple oral administration

Drug: HSG4112

Placebo 720 mg

PLACEBO COMPARATOR

60 mg placebo tablet, 12 tablets, once-daily, 14-day multiple oral administration

Drug: Placebo

Interventions

HSG4112 DRUG

Once-daily, 14-day multiple oral administration

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

HSG4112 480 mg; HSG4112 720 mg

Placebo DRUG

Once-daily, 14-day multiple oral administration

Placebo 480 mg; Placebo 720 mg

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glaceum: lead
• Kyungpook National University Hospital: collaborator
• Seoul National University Hospital: collaborator

Study Sites (2)

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Young-Ran Yoon

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 11, 2021
• Study Start: February 15, 2021
• Primary Completion: January 20, 2022
• Study Completion: February 3, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)