Safety, PK, and PD Comparison of UI059 and UIC202201 in Healthy Volunteers

NCT07727629 | Not Yet Recruiting Phase 1

• 1 other identifier: KUP-UI059-103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gastro Esophageal Reflux Disorder

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss

  day1: 0-24 hours / day 5, day 6: 0 hour / day 7: 0-24 hours

• Percent decrease from baseline in integrated gastric acidity

  Day -1(0 hour) - Day 1(0 hour) / Day1(0 hour) - Day2(0 hour) / Day7(0 hour) - Day7(24 hour)

Study Arms (2)

UI059

EXPERIMENTAL

Drug: UI059

UIC202201

ACTIVE COMPARATOR

Drug: UIC202201

Interventions

UI059 DRUG

take UI059 once a day for 7 days

UI059

UIC202201 DRUG

take UIC202201 once a day for 7 days

UIC202201

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

Chungbuk national university hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Study Officials

• Minkyu Park, MD, PhD

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minkyu Park, MD, PhD

CONTACT

+82432698708; mk_park@cbnuhctc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-03

Locations

KR (1)