DiabetesPhase 1NCT06552182
Phase 1 Study in Diabetes Mellitus(Fasting)
A Phase 1 study testing HUC2-344 and HUC2-344-R1, HUC2-344-R2 in people with Diabetes and Diabetes Mellitus, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
An open-label, randomized, fasting, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus
- What is being tested?
- HUC2-344 and HUC2-344-R1, HUC2-344-R2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2024to 18 Mar 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult aged over 19 at screening
- Those whose BMI is between 18kg/m2 and 30kg/m2
- Those weight over 50kg(female 45kg)
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Who cannot join
- Those who have clinically significant diseases or medical history below lists.
- Skin/mucous membranes
- Head and neck
- Eyes/appendages
- Ear, nose, and throat
- Thyroid/endocrine system
Show all 38Show fewer
- Lungs/respiratory system
- Heart/circulatory system
- Abdomen/digestive system
- Kidney/urinary reproductive system
- Spine/musculoskeletal system
- Nervous/psychiatric system
- Blood/lymph/tumor
- Allergy/immune system
- Drug hypersensitivity
- Within 30 days prior to the first dose, the individual took medications significantly inducing or inhibiting drug-metabolizing enzymes such as barbiturates, or within 10 days prior to the first dose, took medications that could affect this study.
- Those who have participated in a bioequivalence study or other clinical trials and received investigational drugs within 6 months prior to the first dosing day.
- Within 8 weeks prior to the first dosing day, Those who have donated whole blood or within 2 weeks donated components, or received a blood transfusion within 4 weeks.
- Those who with a history of gastrointestinal resection surgery (excluding appendectomy or hernia repair) that could affect drug absorption, or those with gastrointestinal disorders.
- Within 1 month prior to the first dosing day, Those who meet the following conditions:
- For males, average alcohol consumption exceeding 21 drinks per week.
- For females, average alcohol consumption exceeding 14 drinks per week.
- Smoking more than an average of 20 cigarettes per day.
- Those who meet the following criteria:
- Known hypersensitivity reactions to active ingredients, excipients of investigational drugs, or non-quinolone drugs.
- Acute or chronic metabolic acidosis including type 1 diabetes mellitus, hyperglycemia, with or without ketoacidosis, or history of ketoacidosis.
- Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m² or severe and advanced renal impairment.
- End-stage renal disease or undergoing dialysis.
- Genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Acute conditions affecting renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, sepsis.
- Acute and unstable congestive heart failure.
- Receiving intravenous administration of iodinated contrast agents for radiographic studies.
- Diabetic ketoacidosis.
- Severe infections or severe systemic disorders.
- Malnutrition, starvation, cachexia, hypothalamic-pituitary dysfunction, or adrenal insufficiency.
- Acute or chronic conditions causing tissue hypoxia such as hepatic dysfunction, respiratory failure, acute myocardial infarction, shock, excessive alcohol consumption, dehydration, diarrhea, vomiting, or gastrointestinal disorders.
- Other reasons deemed unsuitable for participation in the clinical trial by the study investigator.
- For female subjects, pregnant, suspected pregnant, or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study After Administration of HUC2-344 and Co-administration of HUC2-344-R1 and HUC2-344-R2 in Healthy Volunteers
An open-label, randomized, fasting, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.
Read the detailed description
An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of HUC2-344 and Co-administration of HUC2-344-R1 and HUC2-344-R2 in Healthy Volunteers.
- Conditions
- Diabetes, Diabetes Mellitus
- Being tested
- HUC2-344, HUC2-344-R1, HUC2-344-R2
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUC2-344Drug
per oral
HUC2-344-R1, HUC2-344-R2Drug
per oral
| Study group | Role | What they receive |
|---|---|---|
| After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2 | Experimental | Take 2 pills of comparative drugs first, and take 1 pill of IP after a 1 week of the break. Receives: Drug: HUC2-344; Drug: HUC2-344-R1, HUC2-344-R2 |
| After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once. | Experimental | Take 1 pill of IP first, and take 2 pills of comparative drugs after a 1 week of the break. Receives: Drug: HUC2-344; Drug: HUC2-344-R1, HUC2-344-R2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration of HUC2-344
Measured: 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours
Tmax
Time of concentration
Measured: 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours
AUCt
Area under the drug concentration-time curve
Measured: 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start17 Jan 2024
- Primary completion15 Feb 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Crossover
- Model description
- healthy volunteers
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seunghyeon Kang, Principal investigator, H+YANGGI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552182
- Sponsor's protocol ID
- HUC2-344-1_FA
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study After Administration of HUC2-344 and Co-administration of HUC2-344-R1 and HUC2-344-R2 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06552182
- Acronym / sponsor ID
- HUC2-344-1_FA
- Conditions
- Diabetes, Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 13 Aug 2024 (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.
An open-label, randomized, fasting, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.
Detailed description
An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of HUC2-344 and Co-administration of HUC2-344-R1 and HUC2-344-R2 in Healthy Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2 | Experimental | Drug: HUC2-344, Drug: HUC2-344-R1, HUC2-344-R2Take 2 pills of comparative drugs first, and take 1 pill of IP after a 1 week of the break. |
| After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once. | Experimental | Drug: HUC2-344, Drug: HUC2-344-R1, HUC2-344-R2Take 1 pill of IP first, and take 2 pills of comparative drugs after a 1 week of the break. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult aged over 19 at screening
- Those whose BMI is between 18kg/m2 and 30kg/m2
- Those weight over 50kg(female 45kg)
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Key exclusion criteria (38 listed)
- Those who have clinically significant diseases or medical history below lists.
- Within 30 days prior to the first dose, the individual took medications significantly inducing or inhibiting drug-metabolizing enzymes such as barbiturates, or within 10 days prior to the first dose, took medications that could affect this study.
- Those who have participated in a bioequivalence study or other clinical trials and received investigational drugs within 6 months prior to the first dosing day.
- Within 8 weeks prior to the first dosing day, Those who have donated whole blood or within 2 weeks donated components, or received a blood transfusion within 4 weeks.
- Those who with a history of gastrointestinal resection surgery (excluding appendectomy or hernia repair) that could affect drug absorption, or those with gastrointestinal disorders.
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 |
|---|---|---|
| HUC2-344per oral | Drug | After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2, After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once. |
| HUC2-344-R1, HUC2-344-R2per oral | Drug | After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2, After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once. |
Primary outcome
Cmax
Time frame: 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours
Maximum concentration of HUC2-344
Tmax
Time frame: 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours
Time of concentration
AUCt
Time frame: 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours
Area under the drug concentration-time curve
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 13 Aug 2024.
Related trials for Diabetes
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
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.
Seunghyeon Kang principal investigator
H+YANGGI 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 HUC2-344 and HUC2-344-R1, HUC2-344-R2 in people with Diabetes and Diabetes Mellitus, run by Huons Co., Ltd. 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 4 inclusion and 38 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 13 Aug 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. 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?
Cmax (time frame: 0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours). The study lists 3 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 13 Aug 2024; AzTrials last refreshed its copy on 1 Nov 2026.