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Healthy volunteers needed to test new Drug's effects

NCT ID NCT07277712

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how a new tablet called IN-M00002 behaves in the body of healthy adults aged 19 to 55. It also checks how food and other medicines (tegoprazan and naproxen) affect the drug. The goal is to gather safety and drug-level information, not to treat any disease.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

19 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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 aged ≥ 19 and ≤ 55 year-old at screening * Body mass index (BMI) ≥ 19.0 kg/m2 and ≤ 27.0 kg/m2 with a body weight ≥ 45 kg at screening * Those determined to be eligible for this study based on the findings of screening such as clinical laboratory tests (hematological test, blood chemistry test, blood coagulation test, urinalysis, test for viruses/bacteria, etc.), vital signs, and electrocardiogram (ECG) which are performed by the investigator according to the properties of medicines * Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening * Those with a capability/willingness to participate throughout the study Exclusion Criteria: * Medical history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, oncological, or immune disease (except for history of simple dental treatment such as tartar, impacted teeth, and third molar teeth) * Previous history of gastrointestinal disease (esophageal disease such as esophageal achalasia or esophageal stricture, inflammatory bowel disease (Crohn's disease, ulcerative colitis)) or surgery (except for simple appendectomy, hernia surgery, tooth extraction, etc.) which may affect drug absorption * Sitting systolic blood pressure \< 90 mmHg or ≥ 140 mmHg or diastolic blood pressure \< 60 mmHg or ≥ 90 mmHg at screening * Following findings of clinical laboratory tests: * ALT or AST value \> twice the upper limit of normal (ULN) * History of periodic alcohol consumption exceeding 210 g/week within 6 months prior to screening (beer (5%) 1 glass (250 mL) = 10 g, soju (20%) 1 glass (50 mL) = 8 g, wine (12%) 1 glass (125 mL) = 12 g) * Has taken any other investigational product within 6 months prior to the first dose of investigational product * History of serious alcohol or drug misuse and abuse within 1 year prior to screening * Administration of drugs known to markedly induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose of the investigational product * Daily use of ≥ 20 cigarettes within 6 months prior to screening * Administration of a prescription or non-prescription drug within 10 days prior to the first dose of the investigational product * Whole blood donation within 2 months prior to the first dose of the investigational product or apheresis donation within 1 month prior to the first dose of the investigational product * Subjects who received a blood transfusion within 1 month prior to the first dose of the investigational product * Those who may be put at an increased risk due to the administration of the investigational product and study participation or have a severe acute/chronic medical or mental condition which may interfere with the interpretation of study results * Subjects with a history of hypersensitivity (e.g., asthma, rhinitis, nasal polyps, urticaria, or allergic reactions) to the components of tegoprazan or naproxen, benzimidazole derivatives, aspirin, or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors) * Subjects currently receiving medications containing atazanavir, nelfinavir, or rilpivirine * Women with a positive pregnancy test, pregnant, or breastfeeding * Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.)) * Subjects unable to consume a high-fat diet provided during Part B of the clinical trial * Subjects who are considered ineligible to participate in this study at the discretion of the investigator

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Jeonbuk National University Hospital

    Jeonju, South Korea

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