Mixed DyslipidemiaPhase 1NCT06932705
A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A
A Phase 1 study testing PA-111 and PA-111A in people with Mixed Dyslipidemia, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 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
- Mixed Dyslipidemia
- What is being tested?
- PA-111 and PA-111A
- 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
- Apr 2025to May 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 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.
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, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.
Read the detailed description
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.
- Conditions
- Mixed Dyslipidemia
- Being tested
- PA-111, PA-111A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA-111Drug
PA-111 1Tab., Per Oral
PA-111ADrug
PA-111A 1Capsule., Per Oral
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (RT) | Experimental | Period 1: Reference (PA-111A), Period 2: Test (PA-111) Receives: Drug: PA-111; Drug: PA-111A |
| Sequence A (TR) | Experimental | Period 1: Test (PA-111), Period 2: Reference (PA-111A), Receives: Drug: PA-111; Drug: PA-111A |
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 PA-111
Measured: pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of PA-111
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 posted17 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiaStudies 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
- NCT06932705
- Sponsor's protocol ID
- PA-111BE
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 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 17 Apr 2025. 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 the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions
- ClinicalTrials.gov ID
- NCT06932705
- Acronym / sponsor ID
- PA-111BE
- Conditions
- Mixed Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 17 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 characteristics of PA-111 in healthy subjects.
Detailed description
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A 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: PA-111, Drug: PA-111APeriod 1: Reference (PA-111A), Period 2: Test (PA-111) |
| Sequence A (TR) | Experimental | Drug: PA-111, Drug: PA-111APeriod 1: Test (PA-111), Period 2: Reference (PA-111A), |
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 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 |
|---|---|---|
| PA-111PA-111 1Tab., Per Oral | Drug | Sequence A (RT), Sequence A (TR) |
| PA-111APA-111A 1Capsule., Per Oral | Drug | Sequence A (RT), Sequence A (TR) |
Primary outcome
Maximum concentration of drug in plasma (Cmax)
Time frame: pre-dose (0hour) to 72hours
Cmax of PA-111
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time frame: pre-dose (0hour) to 72hours
AUCt of PA-111
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 17 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Mixed Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia
RecruitingPhase 1/2
Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia
Hyperlipidemia; Mixed
Active, not recruitingObservational study
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingObservational study
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemiia, Mixed Dyslipidemia
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 PA-111 and PA-111A in people with Mixed Dyslipidemia, 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 17 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 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 17 Apr 2025.