Gastro Esophageal Reflux DisorderPhase 1NCT07727629
Safety, PK, and PD Comparison of UI059 and UIC202201 in Healthy Volunteers
A Phase 1 study testing UI059 and UIC202201 in people with Gastro Esophageal Reflux Disorder, run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial summary
A randomized, open-label, multiple-dose, crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux Disorder
- What is being tested?
- UI059 and UIC202201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2026to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 volunteers aged 19 years or older at the time of screening.
- Weight and Body Mass Index (BMI) at screening as follows:
- Body weight: ≥50.0kg for males, ≥45.0kg for females.
- BMI: ≥18.0mg/m2 and ≤ 30.0kg/m2
- Subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings based on medical examination.
- Subjects judged suitable for the clinical trial based on laboratory tests, vital signs, physical examination, and 12-lead ECG conducted at screening.
- Subjects who test negative for H.pylori antibody at screening.
- Subjects who voluntarily decide to participate and provide written informed consent after being fully informed of and understanding the details of this clinical trial and the subject compliance requirements.
Who cannot join
- Current or past history of clinically significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, gastrointestinal, or musculoskeletal diseases.
- History of gastrointestinal diseases (e.g., Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy, hernia repair, or dental procedures) that may affect the absorption of the investigational product.
- Pregnant (positive Urine-HCG test) or breastfeeding women.
- History of clinically significant hypersensitivity (e.g., anaphylaxis or angioedema) to the investigational product ingredients, excipients, or other drugs (e.g., aspirin, penicillin-type antibiotics, macrolide antibiotics, etc.).
- Clinically significant findings on 12-lead ECG at screening, including:
- QTc>450ms(males) or >470ms(females)
Show all 28Show fewer
- PR intervals>200ms
- QRS duration>120ms
- Clinically significant laboratory results at screening, including:
- Liver function (AST, ALT, ALP, γ-GT, and total bilirubin) exceeding 2 times the upper limit of normal (ULN).
- Serum creatinine outside the reference range, or eGFR calculated by the CKD-EPI formula < 60 mL/min/1.73m2.
- History of drug abuse or a positive response to drugs of abuse in the urine drug screen.
- Vital signs measured in a sitting position after at least 3 minutes of rest at screening:
- Systolic Blood Pressure ≤ 90 mmHg or ≥ 150 mmHg
- Diastolic Blood Pressure ≤ 60 mmHg or ≥ 100 mmHg
- Pulse Rate ≤ 40 bpm or ≥ 100 bpm
- Abnormal diet or consumption of food that may affect the absorption, distribution, metabolism, and excretion (ADME) of the investigational product.
- Use of any prescription drugs or herbal medicines within 2 weeks, or any over-the-counter (OTC) drugs or health functional foods within 10 days before the first dose (unless deemed by the investigator not to affect the PK of the investigational product).
- Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 1 month before the first dose.
- Participation and dosing in another clinical trial within 6 months before the first dose.
- Whole blood donation within 2 months, component donation within 1 month, or blood transfusion within 1 month before the first dose; or inability to refrain from donation during the study.
- Consistent alcohol consumption exceeding 21 units/week (1 unit = 10g of pure alcohol) within 6 months before the first dose, or inability to abstain from alcohol during the study.
- Smokers who averaged > 10 cigarettes/day within 3 months before the first dose, or inability to quit smoking from 48 hours before the first dose until the last PK blood collection.
- Consumption of food containing grapefruit within 72 hours before the first dose, or inability to abstain during the study.
- Consumption of food containing caffeine (coffee, tea, soda, etc.) from 48 hours before each first dose until the last PK blood collection, or inability to abstain.
- Strenuous exercise exceeding normal daily activities within 72 hours before the first dose, or inability to refrain from such exercise.
- Subjects (or their partners) planning pregnancy, or those not using medically accepted methods of contraception (e.g., hormonal contraceptives, IUD, sterilization, barrier methods) from the time of consent until 2 weeks after the last dose.
- Any other reason the investigator deems the subject unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Chungbuk national university hospital
Cheongju-si, North Chungcheong, 28644
Minkyu Park, MD, PhD, +821057170713, mk_park@cbnuhctc.com
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics Characteristics After Oral Administration of UI059 and UIC202201 in Healthy Adult Volunteers
A randomized, open-label, multiple-dose, crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers
- Conditions
- Gastro Esophageal Reflux Disorder
- Being tested
- UI059, UIC202201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UI059Drug
take UI059 once a day for 7 days
UIC202201Drug
take UIC202201 once a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| UI059 | Experimental | Not described Receives: Drug: UI059 |
| UIC202201 | Active comparator | Not described Receives: Drug: UIC202201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss
Measured: day1: 0-24 hours / day 5, day 6: 0 hour / day 7: 0-24 hours
Percent decrease from baseline in integrated gastric acidity
Measured: Day -1(0 hour) - Day 1(0 hour) / Day1(0 hour) - Day2(0 hour) / Day7(0 hour) - Day7(24 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal Reflux DisorderStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minkyu Park, MD, PhD, Principal investigator, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727629
- Sponsor's protocol ID
- KUP-UI059-103
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics Characteristics After Oral Administration of UI059 and UIC202201 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07727629
- Acronym / sponsor ID
- KUP-UI059-103
- Conditions
- Gastro Esophageal Reflux Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Jul 2026 (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.
A randomized, open-label, multiple-dose, crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI059 | Experimental | Drug: UI059 |
| UIC202201 | Active comparator | Drug: UIC202201 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adult volunteers aged 19 years or older at the time of screening.
- Weight and Body Mass Index (BMI) at screening as follows:
- Subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings based on medical examination.
- Subjects judged suitable for the clinical trial based on laboratory tests, vital signs, physical examination, and 12-lead ECG conducted at screening.
- Subjects who test negative for H.pylori antibody at screening.
Key exclusion criteria (28 listed)
- Current or past history of clinically significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, gastrointestinal, or musculoskeletal diseases.
- History of gastrointestinal diseases (e.g., Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy, hernia repair, or dental procedures) that may affect the absorption of the investigational product.
- Pregnant (positive Urine-HCG test) or breastfeeding women.
- History of clinically significant hypersensitivity (e.g., anaphylaxis or angioedema) to the investigational product ingredients, excipients, or other drugs (e.g., aspirin, penicillin-type antibiotics, macrolide antibiotics, etc.).
- Clinically significant findings on 12-lead ECG at screening, including:
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 |
|---|---|---|
| UI059take UI059 once a day for 7 days | Drug | UI059 |
| UIC202201take UIC202201 once a day for 7 days | Drug | UIC202201 |
Primary outcome
AUCτ,ss
Time frame: day1: 0-24 hours / day 5, day 6: 0 hour / day 7: 0-24 hours
Percent decrease from baseline in integrated gastric acidity
Time frame: Day -1(0 hour) - Day 1(0 hour) / Day1(0 hour) - Day2(0 hour) / Day7(0 hour) - Day7(24 hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Minkyu Park, MD, PhD principal investigator
Chungbuk 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 UI059 and UIC202201 in people with Gastro Esophageal Reflux Disorder, run by Korea United Pharm. Inc. 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 8 inclusion and 28 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: opening soon, as of the sponsor's last update on 27 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minkyu Park, MD, PhD (+82432698708, mk_park@cbnuhctc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCτ,ss (time frame: day1: 0-24 hours / day 5, day 6: 0 hour / day 7: 0-24 hours). The study lists 2 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 27 Jul 2026.