Diabetes Mellitus, Type 2Phase 1NCT05642377
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HGR4113 in Healthy Subjects
A Phase 1 study testing HGR4113 in people with Diabetes Mellitus, Type 2, run by Glaceum at 1 site in South Korea.
Trial summary
1. Study Objective: The objective of this study is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics, and food effect of HGR4113 after single and multiple oral administration in healthy subjects. 2. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HGR4113
- 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
- 1 siteSouth Korea
- Study dates
- 22 Nov 2022to 31 Jan 2025
- 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.
- Adult volunteers between 19 and 50 years of age at Screening.
- Body mass index (BMI) between 18.0 and 24.9.
- ☞ BMI (kg/m^2) = 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 tests 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., Chron's disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the safety or pharmacokinetic/pharmacodynamic evaluation of the investigational product.
- Significant history or clinical manifestation of hypersensitivity to any drug including licorice or other drug (e.g., aspirin, antibiotics).
- One or more of the following laboratory test results at Screening:
- ANC < 1000
- AST, ALT, GGT, total bilirubin > 1.5x upper limit normal
Show all 25Show fewer
- Fasting glucose ≥ 126 mg/dL or HbA1c ≥ 6.5% despite two retests
- eGFR < 60 (CKD-EPI).
- Systolic blood pressure < 90 mmHg or > 150 mmHg, or diastolic blood pressure < 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.
- Used 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 within 6 months prior to dosing.
- 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.
- Alcohol consumption > 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol 3 days prior to first dosing until the last pharmacokinetic blood sampling.
- History of smoking within 90 days prior to dosing (however, participation is acceptable if the subject has quit at least 90 days prior to dosing) or unable to abstain from smoking 90 days prior to dosing until the last pharmacokinetic blood sampling.
- Ingestion of grapefruit-containing foods or beverages 24 hours 3 days prior to dosing until the last pharmacokinetic blood sampling, or unable to abstain from ingesting such foods or beverages during the same period.
- Unable to abstain from ingesting caffeine-containing foods or beverages (e.g., coffee, tea [e.g., black tea, green tea], soft drinks, coffee milk, energy drinks, sports drinks) 3 days prior to dosing until the last pharmacokinetic blood sampling.
- Females, excluding those who have amenorrhea for at least 12 months or have been surgically sterilized (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), who are pregnant or lactating, evidenced by a positive urine hCG pregnancy test.
- Subject or subject's partner is unable or unwilling to use a medically acceptable means of contraception during and for 90 days following the last dosing or willing to donate sperm during the same period.
- Acceptable contraceptive methods include:
- Use of an intrauterine device that has been proven highly effective
- Male or female physical contraceptive used with chemical sterilization
- 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 other reasons.
- Subject who is confirmed as the CYP2C19 poor metabolizer (e.g., *2/*2, *2/*3, *3/*3) by exploratory genotyping test at Screening in MAD group.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Kyung Sang Yu, MD, PhD
Kyung Sang Yu, MD, PhD
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Single and Multiple Dosing, Dose-Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect After Oral Administration of HGR4113 in Healthy Subjects
- Study Objective: The objective of this study is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics, and food effect of HGR4113 after single and multiple oral administration in healthy subjects.
- Study Design and Plan: This study is a randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase 1 clinical trial. Volunteers who have been deemed eligible based on the inclusion/exclusion criteria will be given a random number. Each subject will be assigned to one of the dose groups in a 6:2 ratio to HGR4113 (active) or placebo. Subjects will be studied in a double-blind manner and will receive the investigational product per protocol. Dose will be escalated once safety data is collected up to the last pharmacokinetic blood collection timepoint and safety and tolerability has been deemed acceptable following the review of the Safety Review Committee. Assessments including vital signs, 12-lead ECG, clinical laboratory, reproductive hormones, physical examination, and monitoring of adverse events concomitant medications will be conducted to evaluate safety and tolerability. Blood will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HGR4113, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGR4113Drug
Once-daily oral administration
PlaceboDrug
Once-daily oral administration
HGR4113Drug
Twice-daily oral administration
PlaceboDrug
Twice-daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| HGR4113 300 mg Single Dose | Experimental | Single oral dosing of HGR4113 300 mg Receives: Drug: HGR4113 |
| Placebo 300 mg Single Dose | Placebo comparator | Single oral dosing of placebo 300 mg Receives: Drug: Placebo |
| HGR4113 600 mg Single Dose | Experimental | Single oral dosing of HGR4113600 mg Receives: Drug: HGR4113 |
| Placebo 600 mg Single Dose | Placebo comparator | Single oral dosing of placebo 600 mg Receives: Drug: Placebo |
| HGR4113 1200 mg Single Dose | Experimental | Single oral dosing of HGR41131200 mg Receives: Drug: HGR4113 |
| Placebo 1200 mg Single Dose | Placebo comparator | Single oral dosing of placebo 1200 mg Receives: Drug: Placebo |
| HGR4113 200 mg Multiple Dose | Experimental | Multiple oral dosing of HGR4113 200 mg, twice daily Receives: Drug: HGR4113 |
| Placebo 200 mg Multiple Dose | Placebo comparator | Multiple oral dosing of placebo 200 mg, twice daily Receives: Drug: Placebo |
| HGR4113 400 mg Multiple Dose | Experimental | Multiple oral dosing of HGR4113 400 mg, twice daily Receives: Drug: HGR4113 |
| Placebo 400 mg Multiple Dose | Placebo comparator | Multiple oral dosing of placebo 400 mg, twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Assessment by Adverse Event Monitoring
Number of participants with observed adverse events
Measured: Day 1 to 7 days after day of 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
Measured: Day 1 to 7 days after day of 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, heart rate, and body temperature
Measured: Day 1 to 7 days after day of 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, blood coagulation, and hormone tests
Measured: Day 1 to 7 days after day of 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
Measured: Day 1 to 7 days after day of last administration
Safety and Tolerability Assessment by Number of Participants with Change in Semen Parameters
Number of participants with clinically significant change in semen assessed through semen volume, semen pH, sperm count, sperm concentration, sperm motility, and sperm morphology
Measured: From Screening to 12 weeks after day of last administration
Pharmacokinetic Assessment by Maximum Plasma Concentration of HGR4113
Maximum Plasma Concentration of HGR4113 (Cmax)
Measured: Hour 0 to 96
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 Over Dosing Interval
Area Under the Plasma Concentration-Time Curve of HGR4113 Over Dosing Interval (AUCtau)
Measured: Hour 0 to 24
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to the Last Measurable Point
Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to the Last Measurable Point (AUClast)
Measured: Hour 0 to 96
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to Infinity
Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to Infinity (AUCinf)
Measured: Hour 0 to 96
Pharmacokinetic Assessment by Half-Life of HGR4113
Half-life of HGR4113 (T1/2)
Measured: Hour 0 to 96
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HGR4113
Time to Maximum Observed Plasma of HGR4113 (Tmax)
Measured: Hour 0 to 96
Pharmacokinetic Assessment by Oral Clearance of HGR4113
Oral Clearance of HGR4113 (CL/F)
Measured: Hour 0 to 96
Pharmacokinetic Assessment by Apparent Volume of Distribution of HGR4113
Volume of Distribution of HGR4113 (Vz/F)
Measured: Hour 0 to 96
Secondary outcomes (5)
Pharmacodynamic Assessment by Change in Paraoxonase 1 Activity
Change in paraoxonase 1 activity
Measured: Day -1 to 17
Pharmacodynamic Assessment by Change in Plasma Glucose
Change in plasma glucose level
Measured: Day -1 to 17
Pharmacodynamic Assessment by Change in Plasma HbA1c
Change in plasma HbA1c level
Measured: Day -1 to 17
Pharmacodynamic Assessment by Change in Plasma Insulin
Change in plasma insulin level
Measured: Day -1 to 17
Pharmacodynamic Assessment by Change in Plasma C-peptide
Change in plasma c-peptide level
Measured: Day -1 to 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start22 Nov 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Glaceum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
- Investigators
- Kyung Sang Yu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642377
- Sponsor's protocol ID
- HGR4113-P1-01
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2022
- Last updated
- 21 Mar 2024
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Single and Multiple Dosing, Dose-Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect After Oral Administration of HGR4113 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05642377
- Acronym / sponsor ID
- HGR4113-P1-01
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GlaceumIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 8 Dec 2022 (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 study is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics, and food effect of HGR4113 after single and multiple oral administration in healthy subjects.
- Study Design and Plan: This study is a randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase 1 clinical trial. Volunteers who have been deemed eligible based on the inclusion/exclusion criteria will be given a random number. Each subject will be assigned to one of the dose groups in a 6:2 ratio to HGR4113 (active) or placebo. Subjects will be studied in a double-blind manner and will receive the investigational product per protocol. Dose will be escalated once safety data is collected up to the last pharmacokinetic blood collection timepoint and safety and tolerability has been deemed acceptable following the review of the Safety Review Committee. Assessments including vital signs, 12-lead ECG, clinical laboratory, reproductive hormones, physical examination, and monitoring of adverse events concomitant medications will be conducted to evaluate safety and tolerability. Blood will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| HGR4113 300 mg Single Dose | Experimental | Drug: HGR4113Single oral dosing of HGR4113 300 mg |
| Placebo 300 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of placebo 300 mg |
| HGR4113 600 mg Single Dose | Experimental | Drug: HGR4113Single oral dosing of HGR4113600 mg |
| Placebo 600 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of placebo 600 mg |
| HGR4113 1200 mg Single Dose | Experimental | Drug: HGR4113Single oral dosing of HGR41131200 mg |
| Placebo 1200 mg Single Dose | Placebo comparator | Drug: PlaceboSingle oral dosing of placebo 1200 mg |
| HGR4113 200 mg Multiple Dose | Experimental | Drug: HGR4113Multiple oral dosing of HGR4113 200 mg, twice daily |
| Placebo 200 mg Multiple Dose | Placebo comparator | Drug: PlaceboMultiple oral dosing of placebo 200 mg, twice daily |
| HGR4113 400 mg Multiple Dose | Experimental | Drug: HGR4113Multiple oral dosing of HGR4113 400 mg, twice daily |
| Placebo 400 mg Multiple Dose | Placebo comparator | Drug: PlaceboMultiple oral dosing of placebo 400 mg, twice daily |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- 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.
- Adult volunteers between 19 and 50 years of age at Screening.
- Body mass index (BMI) between 18.0 and 24.9.
- ☞ BMI (kg/m^2) = 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 tests at Screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
Key exclusion criteria (25 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., Chron's disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the safety or pharmacokinetic/pharmacodynamic evaluation of the investigational product.
- Significant history or clinical manifestation of hypersensitivity to any drug including licorice or other drug (e.g., aspirin, antibiotics).
- One or more of the following laboratory test results at Screening:
- Systolic blood pressure < 90 mmHg or > 150 mmHg, or diastolic blood pressure < 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 |
|---|---|---|
| HGR4113Once-daily oral administration | Drug | HGR4113 1200 mg Single Dose, HGR4113 300 mg Single Dose, HGR4113 600 mg Single Dose |
| PlaceboOnce-daily oral administration | Drug | Placebo 1200 mg Single Dose, Placebo 300 mg Single Dose, Placebo 600 mg Single Dose |
| HGR4113Twice-daily oral administration | Drug | HGR4113 200 mg Multiple Dose, HGR4113 400 mg Multiple Dose |
| PlaceboTwice-daily oral administration | Drug | Placebo 200 mg Multiple Dose, Placebo 400 mg Multiple Dose |
Primary outcome
Safety and Tolerability Assessment by Adverse Event Monitoring
Time frame: Day 1 to 7 days after day of last administration
Number of participants with observed adverse events
Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination
Time frame: Day 1 to 7 days after day of last administration
Number of participants with clinically significant change in physical examination
Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs
Time frame: Day 1 to 7 days after day of last administration
Number of participants with clinically significant change in vital signs including blood pressure, heart rate, and body temperature
Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test
Time frame: Day 1 to 7 days after day of last administration
Number of participants with clinically significant change in laboratory test assessed through hematology, blood biochemistry, urinalysis, blood coagulation, and hormone tests
Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram
Time frame: Day 1 to 7 days after day of last administration
Number of participants with clinically significant change in 12-lead electrocardiogram
Safety and Tolerability Assessment by Number of Participants with Change in Semen Parameters
Time frame: From Screening to 12 weeks after day of last administration
Number of participants with clinically significant change in semen assessed through semen volume, semen pH, sperm count, sperm concentration, sperm motility, and sperm morphology
Pharmacokinetic Assessment by Maximum Plasma Concentration of HGR4113
Time frame: Hour 0 to 96
Maximum Plasma Concentration of HGR4113 (Cmax)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 Over Dosing Interval
Time frame: Hour 0 to 24
Area Under the Plasma Concentration-Time Curve of HGR4113 Over Dosing Interval (AUCtau)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to the Last Measurable Point
Time frame: Hour 0 to 96
Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to the Last Measurable Point (AUClast)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to Infinity
Time frame: Hour 0 to 96
Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to Infinity (AUCinf)
Pharmacokinetic Assessment by Half-Life of HGR4113
Time frame: Hour 0 to 96
Half-life of HGR4113 (T1/2)
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HGR4113
Time frame: Hour 0 to 96
Time to Maximum Observed Plasma of HGR4113 (Tmax)
Pharmacokinetic Assessment by Oral Clearance of HGR4113
Time frame: Hour 0 to 96
Oral Clearance of HGR4113 (CL/F)
Pharmacokinetic Assessment by Apparent Volume of Distribution of HGR4113
Time frame: Hour 0 to 96
Volume of Distribution of HGR4113 (Vz/F)
5 secondary outcomes
Pharmacodynamic Assessment by Change in Paraoxonase 1 Activity
Time frame: Day -1 to 17
Pharmacodynamic Assessment by Change in Plasma Glucose
Time frame: Day -1 to 17
Pharmacodynamic Assessment by Change in Plasma HbA1c
Time frame: Day -1 to 17
Pharmacodynamic Assessment by Change in Plasma Insulin
Time frame: Day -1 to 17
Pharmacodynamic Assessment by Change in Plasma C-peptide
Time frame: Day -1 to 17
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- 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.
Kyung Sang Yu, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HGR4113 in people with Diabetes Mellitus, Type 2, run by Glaceum at 1 site 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 25 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youngah Kim (82-31-8002-2558, yakim116@glaceum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability Assessment by Adverse Event Monitoring (time frame: Day 1 to 7 days after day of last administration). The study lists 14 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 21 Mar 2024.