Gastroesophageal Reflux Disease (GERD)Phase 1NCT06916130
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A
A Phase 1 study testing AD-120A and AD-120 in people with Gastroesophageal Reflux Disease (GERD), run by Addpharma Inc. at 1 site in South Korea.
Trial summary
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- AD-120A and AD-120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2025to 1 Sep 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 and equal to or less than 50 in healthy volunteers at the time of screening visit
- Negative result from Serum Helicobacter pylori antibody at the time of screening visit
Who cannot join
- Patients with trouble performing pH monitor catheter
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Seung Hwan Lee, M.D., Ph.D. contact
South Korea1 site
Seoul National University Hospital
Seoul
Seunghwan Lee Lee, M.D.,PhD
About this study
Official title: A Randomized, Open-label, Multiple Oral-dose, 2x2 Crossover Clinical Trial to Compare the Safety, Pharmacokinetic, and Pharmacodynamic Characteristics of a AD-120 and AD-120A in Healthy Adult Volunteers
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.
Read the detailed description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- AD-120A, AD-120
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-120ADrug
Also called Reference Drug
Administered before the breakfast during 7 days, Oral, Tablet
AD-120Drug
Also called Test drug
Administered before the breakfast during 7 days, Oral, Tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | Experimental | Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A) Receives: Drug: AD-120A; Drug: AD-120 |
| Arm-B | Experimental | Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120) Receives: Drug: AD-120A; Drug: AD-120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
AUCτ,ss after 7days repeated administration of Omeprazole
Measured: AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
The time of peak concentration after single dose
Tmax after 1days administration of Omeprazole
Measured: Tmax: from pre-dose to 24 hours of 1st administration
Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring
Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose
Measured: 24 hours before 1st administration to 24 hours after repeated administration (7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start21 Apr 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by Addpharma Inc.The 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
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916130
- Sponsor's protocol ID
- AD-120PK/PD
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Oral-dose, 2x2 Crossover Clinical Trial to Compare the Safety, Pharmacokinetic, and Pharmacodynamic Characteristics of a AD-120 and AD-120A in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06916130
- Acronym / sponsor ID
- AD-120PK/PD
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Apr 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.
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.
Detailed description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-A | Experimental | Drug: AD-120A, Drug: AD-120Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A) |
| Arm-B | Experimental | Drug: AD-120A, Drug: AD-120Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 and equal to or less than 50 in healthy volunteers at the time of screening visit
- Negative result from Serum Helicobacter pylori antibody at the time of screening visit
Key exclusion criteria (1 listed)
- Patients with trouble performing pH monitor catheter
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 |
|---|---|---|
| AD-120AAlso: Reference DrugAdministered before the breakfast during 7 days, Oral, Tablet | Drug | Arm-A, Arm-B |
| AD-120Also: Test drugAdministered before the breakfast during 7 days, Oral, Tablet | Drug | Arm-A, Arm-B |
Primary outcome
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)
Time frame: AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)
AUCτ,ss after 7days repeated administration of Omeprazole
The time of peak concentration after single dose
Time frame: Tmax: from pre-dose to 24 hours of 1st administration
Tmax after 1days administration of Omeprazole
Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring
Time frame: 24 hours before 1st administration to 24 hours after repeated administration (7days)
Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose
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 8 Apr 2025.
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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.
Seung Hwan Lee, M.D., Ph.D. contact
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 AD-120A and AD-120 in people with Gastroesophageal Reflux Disease (GERD), run by Addpharma Inc. 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 3 inclusion and 1 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 8 Apr 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 Hanna Yang (+82-31-891-6918, hnyang@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss) (time frame: AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)). 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 8 Apr 2025.