ObesityPhase 1NCT04732988
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect 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: 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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy 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
- 90 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 Aug 2018to 24 May 2021
- 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
- Men only
- 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.
- Males 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.
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 of more of the following laboratory test results at screening:
- ALT (SGPT) > 60 IU/L
- Glucose (fasting) > 110 mg/dL or < 70 mg/dL
Show all 23Show fewer
- Testosterone <2.49 ng/mL or > 8.36 ng/mL
- 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 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, or receipt of blood products within 1 month prior to dosing.
- Alcohol consumption of > 20 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
- Smoked within 90 days prior to dosing. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
- Smoker. However, participation is acceptable if the subject has quit smoking at least 3 months 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.
- 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.
- Subjects who, in the opinion of the Investigator, should not participate 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-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112 After Oral Administration in Healthy and Obese Male Subjects
- 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.
- 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.
- 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 oral administration
PlaceboDrug
Once-daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| HSG4112 30 mg Single Dose | Experimental | Single oral dosing of HSG4112 30 mg Receives: Drug: HSG4112 |
| Placebo 30 mg Single Dose | Placebo comparator | Single oral dosing of Placebo 30 mg Receives: Drug: Placebo |
| HSG4112 60 mg Single Dose | Experimental | Single oral dosing of HSG4112 60 mg Receives: Drug: HSG4112 |
| Placebo 60 mg Single Dose | Placebo comparator | Single oral dosing of Placebo 60 mg Receives: Drug: Placebo |
| HSG4112 120 mg Single Dose | Experimental | Single oral dosing of HSG4112 120 mg Receives: Drug: HSG4112 |
| Placebo 120 mg Single Dose | Placebo comparator | Single oral dosing of Placebo 120 mg Receives: Drug: Placebo |
| HSG4112 240 mg Single Dose (Fasted) | Experimental | Single oral dosing of HSG4112 240 mg under fasted conditions Receives: Drug: HSG4112 |
| HSG4112 240 mg Single Dose (Fed) | Experimental | Single oral dosing of HSG4112 240 mg under fed conditions Receives: Drug: HSG4112 |
| Placebo 240 mg Single Dose | Placebo comparator | Single oral dosing of Placebo 240 mg Receives: Drug: Placebo |
| HSG4112 480 mg Single Dose | Experimental | Single oral dosing of HSG4112 480 mg Receives: Drug: HSG4112 |
| Placebo 480 mg Single Dose | Placebo comparator | Single oral dosing of Placebo 480 mg Receives: Drug: Placebo |
| HSG4112 720 mg Single Dose | Experimental | Single oral dosing of HSG4112 720 mg Receives: Drug: HSG4112 |
| Placebo 720 mg Single Dose | Placebo comparator | Single oral dosing of Placebo 720 mg Receives: Drug: Placebo |
| HSG4112 240 mg Multiple Dose | Experimental | Once-daily multiple oral dosing of HSG4112 240 mg for 14 days Receives: Drug: HSG4112 |
| Placebo 240 mg Multiple Dose | Placebo comparator | Once-daily multiple oral dosing of Placebo 240 mg for 14 days Receives: Drug: Placebo |
| HSG4112 480 mg Multiple Dose | Experimental | Once-daily multiple oral dosing of HSG4112 480 mg for 14 days Receives: Drug: HSG4112 |
| Placebo 480 mg Multiple Dose | Placebo comparator | Once-daily multiple oral dosing of Placebo 480 mg for 14 days 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)
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 Plasma Concentration of HSG4112
Maximum plasma concentration of HSG4112 (Cmax)
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 (CL/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 Adverse Event Monitoring
Number of participants with observed adverse events
Measured: Up to 12 weeks from day of last dosing
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: Up to 3 weeks from day of last dosing
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: Up to 3 weeks from day of last dosing
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: Up to 3 weeks from day of last dosing
Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination
Number of participants with clinically significant change in physical examination
Measured: Up to 3 weeks from day of last dosing
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
Measured: Up to 12 weeks from day of last dosing
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
Measured: Up to 12 weeks from day of last dosing
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
Measured: Up to 12 weeks from day of last dosing
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
Measured: Up to 12 weeks from day of last dosing
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
Measured: Up to 12 weeks from day of last dosing
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
Measured: 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
Measured: Day 1 and 14 pre-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start23 Aug 2018
- Primary completion24 May 2021
- Study completion24 May 2021
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaceum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Kyungpook National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732988
- Sponsor's protocol ID
- HSG4112-P1-01
- Status last verified
- Oct 2021
- First submitted
- 19 Jan 2021
- Last updated
- 1 Nov 2021
- 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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112 After Oral Administration in Healthy and Obese Male Subjects
- ClinicalTrials.gov ID
- NCT04732988
- Acronym / sponsor ID
- HSG4112-P1-01
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- GlaceumIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Kyungpook National University Hospital
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 1 Feb 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: 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| HSG4112 30 mg Single Dose | Experimental | Drug: HSG4112Single oral dosing of HSG4112 30 mg |
| Placebo 30 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of Placebo 30 mg |
| HSG4112 60 mg Single Dose | Experimental | Drug: HSG4112Single oral dosing of HSG4112 60 mg |
| Placebo 60 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of Placebo 60 mg |
| HSG4112 120 mg Single Dose | Experimental | Drug: HSG4112Single oral dosing of HSG4112 120 mg |
| Placebo 120 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of Placebo 120 mg |
| HSG4112 240 mg Single Dose (Fasted) | Experimental | Drug: HSG4112Single oral dosing of HSG4112 240 mg under fasted conditions |
| HSG4112 240 mg Single Dose (Fed) | Experimental | Drug: HSG4112Single oral dosing of HSG4112 240 mg under fed conditions |
| Placebo 240 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of Placebo 240 mg |
| HSG4112 480 mg Single Dose | Experimental | Drug: HSG4112Single oral dosing of HSG4112 480 mg |
| Placebo 480 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of Placebo 480 mg |
| HSG4112 720 mg Single Dose | Experimental | Drug: HSG4112Single oral dosing of HSG4112 720 mg |
| Placebo 720 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of Placebo 720 mg |
| HSG4112 240 mg Multiple Dose | Experimental | Drug: HSG4112Once-daily multiple oral dosing of HSG4112 240 mg for 14 days |
| Placebo 240 mg Multiple Dose | Placebo comparator | Drug: PlaceboOnce-daily multiple oral dosing of Placebo 240 mg for 14 days |
| HSG4112 480 mg Multiple Dose | Experimental | Drug: HSG4112Once-daily multiple oral dosing of HSG4112 480 mg for 14 days |
| Placebo 480 mg Multiple Dose | Placebo comparator | Drug: PlaceboOnce-daily multiple oral dosing of Placebo 480 mg for 14 days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
- Males 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.
Key exclusion criteria (23 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 of more of the following laboratory test results at screening:
- 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.
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 oral administration | Drug | HSG4112 120 mg Single Dose, HSG4112 240 mg Multiple Dose, HSG4112 240 mg Single Dose (Fasted), HSG4112 240 mg Single Dose (Fed), HSG4112 30 mg Single Dose, HSG4112 480 mg Multiple Dose, HSG4112 480 mg Single Dose, HSG4112 60 mg Single Dose, HSG4112 720 mg Single Dose |
| PlaceboOnce-daily oral administration | Drug | Placebo 120 mg Single Dose, Placebo 240 mg Multiple Dose, Placebo 240 mg Single Dose, Placebo 30 mg Single Dose, Placebo 480 mg Multiple Dose, Placebo 480 mg Single Dose, Placebo 60 mg Single Dose, Placebo 720 mg Single Dose |
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)
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 Plasma Concentration of HSG4112
Time frame: Hour 0 to 192
Maximum plasma concentration of HSG4112 (Cmax)
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 (CL/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 Adverse Event Monitoring
Time frame: Up to 12 weeks from day of last dosing
Number of participants with observed adverse events
Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs
Time frame: Up to 3 weeks from day of last dosing
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: Up to 3 weeks from day of last dosing
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: Up to 3 weeks from day of last dosing
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 Number of Patients with Change in Physical Examination
Time frame: Up to 3 weeks from day of last dosing
Number of participants with clinically significant change in physical examination
Safety and Tolerability Assessment by Number of Patients with Change in Semen Volume
Time frame: Up to 12 weeks from day of last dosing
Pre-to-post examination of semen volume (milliliters) by semen analysis to assess the safety and tolerability of HSG4112
Safety and Tolerability Assessment by Number of Patients with Change in Semen pH
Time frame: Up to 12 weeks from day of last dosing
Pre-to-post examination of semen white blood cells (10^3 per microliter) by semen analysis to assess the safety and tolerability of HSG4112
Safety and Tolerability Assessment by Number of Patients with Change in Semen White Blood Cells
Time frame: Up to 12 weeks from day of last dosing
Pre-to-post examination of semen white blood cells (10^3 per microliter) by semen analysis to assess the safety and tolerability of HSG4112
Safety and Tolerability Assessment by Number of Patients with Change in Sperm Count
Time frame: Up to 12 weeks from day of last dosing
Pre-to-post examination of sperm count (10^6 per milliliter) by semen analysis to assess the safety and tolerability of HSG4112
Safety and Tolerability Assessment by Number of Patients with Change in Sperm Motility
Time frame: Up to 12 weeks from day of last dosing
Pre-to-post examination of sperm motility (percent of sperm with normal motility) by semen analysis to assess the safety and tolerability of HSG4112
Safety and Tolerability Assessment by Number of Patients with Change in Sperm Morphology
Time frame: Up to 12 weeks from day of last dosing
Pre-to-post examination of sperm morphology (percent of normal sperm) by semen analysis to assess the safety and tolerability of HSG4112
1 secondary outcome
Pharmacodynamic Assessment by Change of Biomarkers
Time frame: Day 1 and 14 pre-dose
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 1 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 5 inclusion and 23 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 1 Nov 2021. 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 19 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 1 Nov 2021.