NCT07727629

Not Yet RecruitingPhase 1

Safety, PK, and PD Comparison of UI059 and UIC202201 in Heal...

Korea United Pharm. Inc.Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

KUP-UI059-103

Study Type

interventional

Estimated enrollment

60

Locations

1 country

Sites

1

Timeline

Study Start

July 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Estimated enrollment: 60 participants
Study completion date: August 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 18, 2026
Actual (reported)
Study Start
July 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
First Posted
July 27, 2026
Actual (reported)
Primary Completion
August 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 27, 2026
Status Verified: March 2026
Last Update Submitted: July 22, 2026

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

UI059Drug

take UI059 once a day for 7 days

UI059

UIC202201Drug

take UIC202201 once a day for 7 days

UIC202201

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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:

Sponsors & Collaborators

Korea United Pharm. Inc.
Industrylead

Study Sites (1)

Chungbuk national university hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Minkyu Park, MD, PhDCONTACT+821057170713 mk_park@cbnuhctc.com

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 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 2026

Estimated (date passed)

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
+13 more criteria

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 27, 2026

Record last verified: 2026-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07727629
Data provider: ClinicalTrials.gov
Source updated: 2026-07-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:35 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

UI059

UIC202201

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations