ObesityPhase 1NCT04703764
A Study to Investigate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of HSG4112
A Phase 1 study testing HSG4112 in people with Obesity, run by Glaceum at 2 sites in South Korea.
Trial summary
1. Study Objective <Part 1> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in healthy female subjects. <Part 2> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in obese… Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- HSG4112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 Feb 2021to 3 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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) 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}
- 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.
Who cannot join
- 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
Show all 47Show fewer
- 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.
- One or more of the following contraception- or pregnancy-related exclusion criteria:
- Females of childbearing potential who are unable or unwilling to use acceptable 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 (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy) of the subject or the subject's male partner.
- 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 this study based on clinical laboratory test results or other reasons.
- <Part 2>
- 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:
- AST > 100 IU/L
- ALT > 100 IU/L
- Cholesterol > 300 mg/dL (subjects who need treatment for their cholesterol level will be excluded)
- Triglyceride > 300 mg/dL
- Glucose (fasting) of 126 mg/dL or higher
- 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.
- Females who have tested positive in a urine HCG test, are pregnant, or lactating before the dosing of an investigational product, excluding females who have experienced amenorrhoea for 12 months or longer or have been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy).
- Unable or unwilling to use contraceptive methods during the study period, up to 30 days after the last day of dosing.
- Acceptable contraceptive methods include:
- Use of an intrauterine device that has been proven highly effective by the subject or the subject's partner.
- Physical contraception (e.g., diaphragm, uterine cap, condom) used with chemical sterilization (e.g., spermicide)
- Surgical sterilization of the subject or the subject's partner (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy).
- Subjects who, in the opinion of the Investigator, should not participate in in this study based on clinical laboratory test results or other reasons.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Kyungpook National University Hospital
Daegu, 41944
Seoul National University Hospital
Seoul, 03080
About this study
Official title: A Dose Blocked-randomized, Double Blind, Placebo-controlled, Multiple Dosing, Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of HSG4112 After Oral Administration in Healthy and Obese Adult Subjects
- Study Objective <Part 1> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in healthy female subjects. <Part 2> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in obese subjects.
- 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. Therefore, this study is designed to evaluate the safety of HSG4112 in healthy female subjects and obese subjects following the administration of HSG4112 under fed conditions.
- Study Design and Plan
<Part 1> 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 and 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 ECG, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharcokinetic/pharmacodynamic characteristics of HSG4112.
<Part 2> 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 and will receive the investigational product (i.e., HSG4112 or placebo) via once-daily oral administration for 14 consecutive days. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead ECG, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharcokinetic/pharmacodynamic characteristics of HSG4112.
- Conditions
- Obesity
- Being tested
- HSG4112, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSG4112Drug
Also called 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol
Once-daily, 14-day multiple oral administration
PlaceboDrug
Once-daily, 14-day multiple oral administration
| Study group | Role | What they receive |
|---|---|---|
| HSG4112 480 mg | Experimental | 60 mg HSG4112 tablet, 8 tablets, once-daily, 14-day multiple oral administration Receives: Drug: HSG4112 |
| Placebo 480 mg | Placebo comparator | 60 mg placebo tablet, 8 tablets, once-daily, 14-day multiple oral administration Receives: Drug: Placebo |
| HSG4112 720 mg | Experimental | 60 mg HSG4112 tablet, 12 tablets, once-daily, 14-day multiple oral administration Receives: Drug: HSG4112 |
| Placebo 720 mg | Placebo comparator | 60 mg placebo tablet, 12 tablets, once-daily, 14-day multiple oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112
Time to maximum observed plasma concentration of HSG4112 (Tmax)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Half-Life of HSG4112
Half-life of HSG4112 (T1/2)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Oral Clearance of HSG4112
Oral clearance of HSG4112 (CLss/F)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Volume of Distribution of HSG4112
Volume of distribution of HSG4112 (Vd/F)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day -1, 1 to 14, 17, and post-study visit
Secondary outcomes (5)
Pharmacodynamic Assessment by Change of Body Weight in Healthy Subjects
Assessment of the weight loss effect of HSG4112 by change of observed body weight compared to baseline (kg)
Measured: Day -1, 8, 15, and 22
Pharmacodynamic Assessment by Change of Body Weight in Obese Subjects
Assessment of the weight loss effect of HSG4112 by change of observed body weight compared to baseline (kg)
Measured: Day 1 to 17, 18, 20, and 22
Pharmacodynamic Assessment by Change of Waist Circumference
Assessment of the weight loss effect of HSG4112 by change of observed waist circumference compared to baseline (cm)
Measured: Day -1, 8, 15, and 22
Pharmacodynamic Assessment by Change of Biomarkers
Assessment of the weight loss effect of HSG4112 by 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
Measured: Day 1 and 14 pre-dose
Pharmacodynamic Assessment by Change of Fat Mass and Body Fat Percentage
Assessment of the weight loss effect of HSG4112 by change of fat mass (kg) and body fat percentage (%) compared to baseline
Measured: Day 1, 8, 15, and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start15 Feb 2021
- Primary completion20 Jan 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaceum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital, Seoul National University Hospital
- Responsible party
- Sponsor
- Investigators
- Young-Ran Yoon, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703764
- Sponsor's protocol ID
- HSG4112-P1-03
- Status last verified
- Sep 2022
- First submitted
- 16 Dec 2020
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Blocked-randomized, Double Blind, Placebo-controlled, Multiple Dosing, Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of HSG4112 After Oral Administration in Healthy and Obese Adult Subjects
- ClinicalTrials.gov ID
- NCT04703764
- Acronym / sponsor ID
- HSG4112-P1-03
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlaceumIndustry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital, Seoul National University Hospital
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Study Objective <Part 1> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in healthy female subjects. <Part 2> To evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after multiple oral administration in obese subjects.
- 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. Therefore, this study is designed to evaluate the safety of HSG4112 in healthy female subjects and obese subjects following the administration of HSG4112 under fed conditions.
- Study Design and Plan
<Part 1> 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 and 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 ECG, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharcokinetic/pharmacodynamic characteristics of HSG4112.
<Part 2> 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 and will receive the investigational product (i.e., HSG4112 or placebo) via once-daily oral administration for 14 consecutive days. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead ECG, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharcokinetic/pharmacodynamic characteristics of HSG4112.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSG4112 480 mg | Experimental | Drug: HSG411260 mg HSG4112 tablet, 8 tablets, once-daily, 14-day multiple oral administration |
| Placebo 480 mg | Placebo comparator | Drug: Placebo60 mg placebo tablet, 8 tablets, once-daily, 14-day multiple oral administration |
| HSG4112 720 mg | Experimental | Drug: HSG411260 mg HSG4112 tablet, 12 tablets, once-daily, 14-day multiple oral administration |
| Placebo 720 mg | Placebo comparator | Drug: Placebo60 mg placebo tablet, 12 tablets, once-daily, 14-day multiple oral administration |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
- 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).
Key exclusion criteria (47 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSG4112Also: 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenolOnce-daily, 14-day multiple oral administration | Drug | HSG4112 480 mg, HSG4112 720 mg |
| PlaceboOnce-daily, 14-day multiple oral administration | Drug | Placebo 480 mg, Placebo 720 mg |
Primary outcome
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
Time frame: Hour 0 to 24
Area under the plasma concentration-time curve of HSG4112 over dosing interval (AUCtau,ss)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point
Time frame: Hour 0 to 192
Area under the plasma concentration-time curve from time zero to the last measurable point (AUClast)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity
Time frame: Hour 0 to 192
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Pharmacokinetic Assessment by Maximum and Minimum Plasma Concentration of HSG4112
Time frame: Hour 0 to 192
Maximum and minimum plasma concentration of HSG4112 (Cmax,ss; Cmin,ss)
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112
Time frame: Hour 0 to 192
Time to maximum observed plasma concentration of HSG4112 (Tmax)
Pharmacokinetic Assessment by Half-Life of HSG4112
Time frame: Hour 0 to 192
Half-life of HSG4112 (T1/2)
Pharmacokinetic Assessment by Oral Clearance of HSG4112
Time frame: Hour 0 to 192
Oral clearance of HSG4112 (CLss/F)
Pharmacokinetic Assessment by Volume of Distribution of HSG4112
Time frame: Hour 0 to 192
Volume of distribution of HSG4112 (Vd/F)
Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs
Time frame: Day 1, 14, and post-study visit
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
Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram
Time frame: Day -1, 11, and post-study visit
Number of participants with clinically significant change in 12-lead electrocardiogram
Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test
Time frame: Day -1, 8, 13, 15, 17, and post-study visit
Number of participants with clinically significant change in laboratory test assessed through hematology, blood biochemistry, urinalysis, and blood coagulation test
Safety and Tolerability Assessment by Pregnancy Test
Time frame: Day -1, 11, and post-study visit
Monitoring the pregnancy status of participants through urine pregnancy test by measuring the level of human chorionic gonadotropin
Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination
Time frame: Day -1, 1 to 14, 17, and post-study visit
Number of participants with clinically significant change in physical examination
5 secondary outcomes
Pharmacodynamic Assessment by Change of Body Weight in Healthy Subjects
Time frame: Day -1, 8, 15, and 22
Pharmacodynamic Assessment by Change of Body Weight in Obese Subjects
Time frame: Day 1 to 17, 18, 20, and 22
Pharmacodynamic Assessment by Change of Waist Circumference
Time frame: Day -1, 8, 15, and 22
Pharmacodynamic Assessment by Change of Biomarkers
Time frame: Day 1 and 14 pre-dose
Pharmacodynamic Assessment by Change of Fat Mass and Body Fat Percentage
Time frame: Day 1, 8, 15, and 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Ran Yoon principal investigator
Kyungpook National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSG4112 in people with Obesity, run by Glaceum at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval (time frame: Hour 0 to 24). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.