Primary HypercholesterolaemiaPhase 1NCT06884098
A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284
A Phase 1 study testing AD-228B and AD-2284 in people with Primary Hypercholesterolaemia, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Hypercholesterolaemia
- What is being tested?
- AD-228B and AD-2284
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2025to Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body weight equal to or greater than 50kg (Female 45kg) and 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 other 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.
South Korea1 site, 1 recruiting
- Recruiting
H Plus Yangji Hospital
Seoul
SeungHyun Kang, +82-70-4665-9490, juspa@newyjh.com
About this study
Official title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-228B with AD-2284 in Healthy Adult Volunteers
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.
- Conditions
- Primary Hypercholesterolaemia
- Being tested
- AD-228B, AD-2284
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-228BDrug
AD-228B, 1Tab., Per Oral
AD-2284Drug
AD-2284, 1Tab., Per Oral
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (RT) | Experimental | Period 1: Reference Drug (AD-2284), Period 2: Test Drug (AD-228B) Receives: Drug: AD-228B; Drug: AD-2284 |
| Sequence B (TR) | Experimental | Period 1: Test Drug (AD-228B), Period 2: Reference Drug (AD-2284) Receives: Drug: AD-228B; Drug: AD-2284 |
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-228B
Measured: pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-228B
Measured: pre-dose (0hour) to 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start10 Mar 2025
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolaemiaStudies of the same condition, open and under way.
- 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
- 60 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
- NCT06884098
- Sponsor's protocol ID
- AD-228BE-H
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 20 Mar 2025
- 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-228B with AD-2284 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06884098
- Acronym / sponsor ID
- AD-228BE-H
- Conditions
- Primary Hypercholesterolaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Mar 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 characteristics of AD-228B in healthy subjects.
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-228B, Drug: AD-2284Period 1: Reference Drug (AD-2284), Period 2: Test Drug (AD-228B) |
| Sequence B (TR) | Experimental | Drug: AD-228B, Drug: AD-2284Period 1: Test Drug (AD-228B), Period 2: Reference Drug (AD-2284) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body weight equal to or greater than 50kg (Female 45kg) and 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 other 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-228BAD-228B, 1Tab., Per Oral | Drug | Sequence A (RT), Sequence B (TR) |
| AD-2284AD-2284, 1Tab., Per Oral | Drug | Sequence A (RT), Sequence B (TR) |
Primary outcome
Maximum concentration of drug in plasma (Cmax)
Time frame: pre-dose (0hour) to 72hours
Cmax of AD-228B
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time frame: pre-dose (0hour) to 72hours
AUCt of AD-228B
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 Mar 2025.
- 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-228B and AD-2284 in people with Primary Hypercholesterolaemia, 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: looking for participants now, as of the sponsor's last update on 20 Mar 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 JeongEun Park (+82-31-891-6989, parkje@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 (0hour) to 72hours). 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 Mar 2025.