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

NCT05310032 | Completed Phase 1

• 1 other identifier: HSG4112-P1-04
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (23)

• Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112

  Maximum Plasma Concentration of HSG4112 (Cmax)

  Hour 0 to 192

• Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112 at Steady State

  Maximum Plasma Concentration of HSG4112 at Steady State (Cmax,ss)

  Hour 0 to 192

• Pharmacokinetic Assessment by Minimum Plasma Concentration of HSG4112 at Steady State

  Minimum Plasma Concentration of HSG4112 at Steady State (Cmin,ss)

  Hour 0 to 192

• Pharmacokinetic Assessment by Average Plasma Concentration of HSG4112 at Steady State

  Average Plasma Concentration of HSG4112 at Steady State (Cavg,ss)

  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 of HSG4112 from Time Zero to Infinity (AUCinf)

  Hour 0 to 192

• Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity at Steady State

  Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity at Steady State (AUCinf,ss)

  Hour 0 to 192

• 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)

  Hour 0 to 24

• Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval at Steady State

  Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval at Steady State (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 of HSG4112 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 the Last Measurable Point at Steady State

  Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point at Steady State (AUClast,ss)

  Hour 0 to 192

• Pharmacokinetic Assessment by Half-Life of HSG4112

  Half-life of HSG4112 (T1/2)

  Hour 0 to 192

• Pharmacokinetic Assessment by Half-Life of HSG4112 at Steady State

  Half-life of HSG4112 at Steady State (T1/2,ss)

  Hour 0 to 192

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

  Time to Maximum Observed Plasma of HSG4112 (Tmax)

  Hour 0 to 192

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

  Time to Maximum Observed Plasma Concentration of HSG4112 at Steady State (Tmax,ss)

  Hour 0 to 192

• Pharmacokinetic Assessment by Oral Clearance of HSG4112

  Oral Clearance of HSG4112 (CL/F)

  Hour 0 to 192

• Pharmacokinetic Assessment by Oral Clearance of HSG4112 at Steady State

  Oral Clearance of HSG4112 at Steady State (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

• Pharmacokinetic Assessment by Volume of Distribution of HSG4112 at Steady State

  Volume of Distribution of HSG4112 at Steady State (Vdss/F)

  Hour 0 to 192

• Safety and Tolerability Assessment by Adverse Event Monitoring

  Number of participants with observed advese events

  Day 1 to 9 following the last administration

• 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 to 9 following the last administration

• 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 to 9 following the last administration

• 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 to 9 following the last administration

• 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 to 9 following the last administration

Secondary Outcomes (5)

• Pharmacodynamic Assessment by Change in Body Weight [Part 2]

  Days 1 to 17, Day 18, Day 20, Day 22 post-dose before first meal

• Pharmacodynamic Assessment by Change in Waist Circumference [Part 2]

  Day 1, Day 8, Day 15, Day 22 post-dose before first meal

• Pharmacodynamic Assessment by Change in Body Fat Mass [Part 2]

  Day 1, Day 8, Day 15, Day 22 post-dose before first meal

• Pharmacodynamic Assessment by Change in Body Fat Percentage [Part 2]

  Day 1, Day 8, Day 15, Day 22 post-dose before first meal

• Pharmacodynamic Assessment by Change of Biomarkers [Part 2]

  Day 1 and 14 pre-dose

Study Arms (6)

HSG4112 800 mg Single Dose

EXPERIMENTAL

Single oral dosing of HSG4112 800 mg

Drug: HSG4112

HSG4112 1200 mg Single Dose

EXPERIMENTAL

Single oral dosing of HSG4112 1200 mg with a high-fat meal or fasting condition, with a washout period of 21 days in between each dosing

Drug: HSG4112

HSG4112 800 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of HSG4112 1200 mg for 14 days

Drug: HSG4112

Placebo 800 mg Multiple Dose

PLACEBO COMPARATOR

Multiple oral dosing of placebo 800 mg for 14 days

Drug: Placebo

HSG4112 1200 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of HSG4112 1200 mg for 14 days

Drug: HSG4112

Placebo 1200mg Multiple Dose

PLACEBO COMPARATOR

Multiple oral dosing of placebo 1200 mg for 14 days

Drug: Placebo

Interventions

HSG4112 DRUG

Once-daily oral adminstration

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

HSG4112 1200 mg Multiple Dose; HSG4112 1200 mg Single Dose; HSG4112 800 mg Multiple Dose; HSG4112 800 mg Single Dose

Placebo DRUG

Once-daily oral adminstration

Placebo 1200mg Multiple Dose; Placebo 800 mg Multiple Dose

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.
• Adults between 19 and 50 years of age at screening.
• Body mass index (BMI) between 18 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 test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
• For Part 2 (i.e., the multiple dose study), female subjects who have regular menstrual cycles(28±7 days) and who are not pregnant or lactating.

You may not qualify if:

• Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, 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-containing drugs, aspirin, antibiotics).
• One or more of the following laboratory test results at screening:
• ALT (SGPT) \> 60 IU/L
• Glucose (fasting) \> 110 mg/dL or \< 70 mg/dL
• 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.
• 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 the 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 90 days 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, starting from 3 days prior to dosing.
• 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
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 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

• Kyung Sang Yu, MD, PhD

  Seoul 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: March 25, 2022
• First Posted: April 4, 2022
• Study Start: April 21, 2022
• Primary Completion: December 12, 2022
• Study Completion: March 31, 2023
• Last Updated: March 20, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)