Diabetes MellitusPhase 1NCT07538466
A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232
A Phase 1 study testing AD-123 and AD-1231 and AD-1232 in people with Diabetes Mellitus, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- AD-123 and AD-1231 and AD-1232
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2026to May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
Who cannot join
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232 in Healthy Adult Volunteers Under Fasting Conditions
A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232
- Conditions
- Diabetes Mellitus
- Being tested
- AD-123, AD-1231 and AD-1232
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-123Drug
AD-123 Oral Tablet
AD-1231 and AD-1232Drug
AD-1231 Oral Tablet + AD-1232 Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (RT) | Experimental | Period 1 : Reference Drug(AD-1231 and AD-1232), Period 2 : Test Drug(AD-123) Receives: Drug: AD-123; Drug: AD-1231 and AD-1232 |
| Sequence B (TR) | Experimental | Period 1 : Test Drug(AD-123), Period 2 : Reference Drug(AD-1231 and AD-1232) Receives: Drug: AD-123; Drug: AD-1231 and AD-1232 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration of drug in plasma (Cmax)
Cmax of AD-123
Measured: pre-dose to 72 hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-123
Measured: pre-dose 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 posted20 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- 50 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
- NCT07538466
- Sponsor's protocol ID
- AD-123BE
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232 in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT07538466
- Acronym / sponsor ID
- AD-123BE
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 20 Apr 2026 (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.
A Study to Evaluate the Safety and Pharmacokinetics of AD-123 Compared to Coadministration of AD-1231 and AD-1232
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A (RT) | Experimental | Drug: AD-123, Drug: AD-1231 and AD-1232Period 1 : Reference Drug(AD-1231 and AD-1232), Period 2 : Test Drug(AD-123) |
| Sequence B (TR) | Experimental | Drug: AD-123, Drug: AD-1231 and AD-1232Period 1 : Test Drug(AD-123), Period 2 : Reference Drug(AD-1231 and AD-1232) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
Key exclusion criteria (2 listed)
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
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-123AD-123 Oral Tablet | Drug | Sequence A (RT), Sequence B (TR) |
| AD-1231 and AD-1232AD-1231 Oral Tablet + AD-1232 Oral Tablet | Drug | Sequence A (RT), Sequence B (TR) |
Primary outcome
Maximum concentration of drug in plasma (Cmax)
Time frame: pre-dose to 72 hours
Cmax of AD-123
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time frame: pre-dose to 72 hours
AUCt of AD-123
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 20 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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-123 and AD-1231 and AD-1232 in people with Diabetes Mellitus, 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 2 inclusion and 2 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 20 Apr 2026. 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 Dasom Kim (+82-31-891-5572, dskim@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration of drug in plasma (Cmax) (time frame: pre-dose to 72 hours). The study lists 2 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 20 Apr 2026.