Healthy VolunteerPhase 1NCT07277712
A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers
A Phase 1 study testing Tegoprazan, Naproxen and IN-M00002 in people with Healthy Volunteer, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Tegoprazan, Naproxen and IN-M00002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Dec 2025to 30 Sep 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
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
Jeonbuk National University Hospital
Jeonju
Seol Ju Moon, MD, PhD, +82-63-270-3087, sjmoon@jbcp.kr
Seol Ju Moon, MD, PhD
About this study
Official title: A Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetics Following Administration of IN-M00002 Tablet and Co-administration of Tegoprazan and Naproxen, and to Evaluate Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers
This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers
Read the detailed description
A randomized, open-label, crossover study
[Part A] To evaluate and compare the pharmacokinetic and safety of co-administration of tegoprazan and naproxen versus administration of IN-M00002 tablet in healthy adult volunteers
[Part B] To evaluate the effects of food on the pharmacokinetic and safety of IN-M00002 tablet in healthy adult volunteers
- Conditions
- Healthy Volunteer
- Being tested
- Tegoprazan, Naproxen, IN-M00002
- Keywords
- pharmacokinetic, food-effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Also called K-CAB
Tegoprazan 25 mg QD
NaproxenDrug
Also called Naxen-F
Naproxen 500 mg BID
IN-M00002Drug
IN-M00002 tablet QD
IN-M00002Drug
IN-M00002 tablet BID
| Study group | Role | What they receive |
|---|---|---|
| Part A: Sequence 1 (Treatment A - Treatment B) | Experimental | Period 1: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID Period 2: Single dose of IN-M00002 tablet BID Receives: Drug: Tegoprazan; Drug: Naproxen; Drug: IN-M00002 |
| Part A: Sequence 2 (Treatment B - Treatment A) | Experimental | Period 1: Single dose of IN-M00002 tablet BID Period 2: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID Receives: Drug: Tegoprazan; Drug: Naproxen; Drug: IN-M00002 |
| Part B: Sequence 1 (Treatment C - Treatment D) | Experimental | Period 1: Single dose of IN-M00002 tablet QD under fasted conditions Period 2: Single dose of IN-M00002 tablet QD under fed conditions Receives: Drug: IN-M00002 |
| Part B: Sequence 2 (Treatment D - Treatment C) | Experimental | Period 1: Single dose of IN-M00002 tablet QD under fed conditions Period 2: Single dose of IN-M00002 tablet QD under fasted conditions Receives: Drug: IN-M00002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of tegoprazan
Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration
Measured: Up to 48 hours
AUCt of naproxen
Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration
Measured: Up to 72 hours
Cmax of tegoprazan
Maximum plasma concentration of tegoprazan
Measured: Up to 48 hours
Cmax of naproxen
Maximum plasma concentration of naproxen
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start27 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- Model description
- \[Part A\] 2-sequence-arm, 2-period crossover study \[Part B\] 2-sequence-arm, 2-period crossover study
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seol Ju Moon, MD, Ph.D, Principal investigator, Clinical Pharmacology Center, Jeonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277712
- Sponsor's protocol ID
- IN_TNA_101
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetics Following Administration of IN-M00002 Tablet and Co-administration of Tegoprazan and Naproxen, and to Evaluate Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07277712
- Acronym / sponsor ID
- IN_TNA_101
- Conditions
- Healthy Volunteer
- Keywords
- pharmacokinetic, food-effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Dec 2025 (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.
This study aims to evaluate the pharmacokinetic (PK) following administration of IN-M00002 tablet and co-administration of tegoprazan and naproxen, and to evaluate food-effect of IN-M00002 tablet in healthy adult volunteers
Detailed description
A randomized, open-label, crossover study
[Part A] To evaluate and compare the pharmacokinetic and safety of co-administration of tegoprazan and naproxen versus administration of IN-M00002 tablet in healthy adult volunteers
[Part B] To evaluate the effects of food on the pharmacokinetic and safety of IN-M00002 tablet in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- [Part A] 2-sequence-arm, 2-period crossover study [Part B] 2-sequence-arm, 2-period crossover study
| Arm | Type | Receives |
|---|---|---|
| Part A: Sequence 1 (Treatment A - Treatment B) | Experimental | Drug: Tegoprazan, Drug: Naproxen, Drug: IN-M00002Period 1: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID Period 2: Single dose of IN-M00002 tablet BID |
| Part A: Sequence 2 (Treatment B - Treatment A) | Experimental | Drug: Tegoprazan, Drug: Naproxen, Drug: IN-M00002Period 1: Single dose of IN-M00002 tablet BID Period 2: Single dose of tegoprazan 25 mg QD in combination with naproxen 500 mg BID |
| Part B: Sequence 1 (Treatment C - Treatment D) | Experimental | Drug: IN-M00002Period 1: Single dose of IN-M00002 tablet QD under fasted conditions Period 2: Single dose of IN-M00002 tablet QD under fed conditions |
| Part B: Sequence 2 (Treatment D - Treatment C) | Experimental | Drug: IN-M00002Period 1: Single dose of IN-M00002 tablet QD under fed conditions Period 2: Single dose of IN-M00002 tablet QD under fasted conditions |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
- 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)
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 |
|---|---|---|
| TegoprazanAlso: K-CABTegoprazan 25 mg QD | Drug | Part A: Sequence 1 (Treatment A - Treatment B), Part A: Sequence 2 (Treatment B - Treatment A) |
| NaproxenAlso: Naxen-FNaproxen 500 mg BID | Drug | Part A: Sequence 1 (Treatment A - Treatment B), Part A: Sequence 2 (Treatment B - Treatment A) |
| IN-M00002IN-M00002 tablet QD | Drug | Part B: Sequence 1 (Treatment C - Treatment D), Part B: Sequence 2 (Treatment D - Treatment C) |
| IN-M00002IN-M00002 tablet BID | Drug | Part A: Sequence 1 (Treatment A - Treatment B), Part A: Sequence 2 (Treatment B - Treatment A) |
Primary outcome
AUCt of tegoprazan
Time frame: Up to 48 hours
Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration
AUCt of naproxen
Time frame: Up to 72 hours
Area under the plasma concentration-time curve from the time of dosing to the time of the last measurable concentration
Cmax of tegoprazan
Time frame: Up to 48 hours
Maximum plasma concentration of tegoprazan
Cmax of naproxen
Time frame: Up to 72 hours
Maximum plasma concentration of naproxen
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 11 Dec 2025.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Seol Ju Moon, MD, Ph.D principal investigator
Clinical Pharmacology Center, Jeonbuk 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 Tegoprazan, Naproxen and IN-M00002 in people with Healthy Volunteer, run by HK inno.N Corporation 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 5 inclusion and 20 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 11 Dec 2025. 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 Seung Hee Jung, PhD (+82-31-5176-4653, shee.jung@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of tegoprazan (time frame: Up to 48 hours). The study lists 4 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 11 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.