Can a new pill beat acid reflux? two drugs go Head-to-Head
NCT ID NCT07727629
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This phase 1 trial tests two experimental oral drugs, UI059 and UIC202201, in healthy adult volunteers to see how safe they are and how well they control stomach acid. Each participant takes one drug daily for a week, then switches to the other after a break. The goal is to compare their effects on acid levels in the stomach and find out which one might work better for treating GERD.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- two experimental oral drugs for GERD, UI059 and UIC202201
- What this could lead to
- If one drug proves safer or more effective at controlling stomach acid, it could become a new treatment option for GERD.
- What could go wrong
- This is an early phase 1 trial in healthy volunteers, not patients with GERD. The drugs may not work as expected or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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) * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chungbuk national university hospital
Cheongju-si, North Chungcheong, 28644, South Korea