HealthyPhase 1NCT04654065
Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers
A Phase 1 study testing IN-C004 in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
To evaluate whether IN-C004 absorbs oral mucosa in healthy 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
- What is being tested?
- IN-C004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2021to 5 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.
Who cannot join
- History or evidence of clinically significant disease
- History of drug/alcohol abuse
- Participated in other studies and received investigational products within 6 months prior to the first study dose.
- Not able to use a medically acceptable contraceptive method throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose Clinical Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers
To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.
Read the detailed description
An Open-label, Single-dose Clinical Study
- Conditions
- Healthy
- Being tested
- IN-C004
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-C004Drug
One time dose of IN-C004 taken orally.
| Study group | Role | What they receive |
|---|---|---|
| IN-C004 | Experimental | IN-C004 Receives: Drug: IN-C004 |
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 of tegoprazan
Measured: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Cmax of tegoprazan
Maximum Plasma Concentration at Steady State of tegoprazan
Measured: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Tmax of tegoprazan
Time to reach Cmax
Measured: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start4 Jan 2021
- Primary completion5 Jan 2021
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654065
- Sponsor's protocol ID
- IN_KOD_101
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Clinical Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04654065
- Acronym / sponsor ID
- IN_KOD_101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 4 Dec 2020 (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.
To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.
Detailed description
An Open-label, Single-dose Clinical Study
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IN-C004 | Experimental | Drug: IN-C004IN-C004 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.
Key exclusion criteria (4 listed)
- History or evidence of clinically significant disease
- History of drug/alcohol abuse
- Participated in other studies and received investigational products within 6 months prior to the first study dose.
- Not able to use a medically acceptable contraceptive method throughout the study.
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 |
|---|---|---|
| IN-C004One time dose of IN-C004 taken orally. | Drug | IN-C004 |
Primary outcome
AUCt of tegoprazan
Time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Area under the plasma concentration-time curve of tegoprazan
Cmax of tegoprazan
Time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Maximum Plasma Concentration at Steady State of tegoprazan
Tmax of tegoprazan
Time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Time to reach Cmax
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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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. This study is not recruiting at the moment.
Min-Gul Kim principal investigator
Chonbuk 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 IN-C004 in people with Healthy, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of tegoprazan (time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours). The study lists 3 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 29 Jan 2021.