HypertensionPhase 1NCT07784621
A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-Drug Interaction Between HUC2A-752-A and HUC2A-752-B in Healthy Adults
A Phase 1 study testing Losartan (COZZAR®) and Pitavastatin plus Ezetemibe in people with Hypertension, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
This study evaluates the pharmacokinetic drug-drug interactions of repeated co-administration of HUC2A-752-A and HUC2A-752-B compared to monotherapy of each agent in healthy adults Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Losartan (COZZAR®) and Pitavastatin plus Ezetemibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2026to Feb 2027
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers
- Individuals with a body weight between 50.0 kg and 90.0 kg and a BMI between 18.5 kg/m² and 29.9 kg/m²
Who cannot join
- Individuals with a history or presence of clinically significant diseases of the following systems: hepatobiliary, renal, neurological, immunological, respiratory, gastrointestinal, endocrine, hematologic/oncologic, cardiovascular , musculoskeletal, urological, psychiatric, or sexual dysfunction.
- Individuals with a history of gastrointestinal diseases or gastrointestinal surgeries that could affect the safety or pharmacokinetic evaluation of the investigational product.
- Individuals with a history of hypersensitivity or clinically significant hypersensitivity reactions to losartan, pitavastatin, ezetimibe, angiotensin receptor blockers, statins, or any other medications.
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
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Seoul National University Hospital, +82-70-7492-6023, jywon@huons.com
About this study
Official title: An Open-Label, Multiple-oral Dosing, Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-Drug Interaction Between HUC2A-752-A and HUC2A-752-B in Healthy Adults
This study evaluates the pharmacokinetic drug-drug interactions of repeated co-administration of HUC2A-752-A and HUC2A-752-B compared to monotherapy of each agent in healthy adults
Read the detailed description
This randomized, open-label, 2-arm, 2-period, multiple-dose, phase 1 clinical trial evaluates the safety, tolerability, and pharmacokinetics of HUC2A-752 following repeated oral administration of HUC2A-752-A and HUC2A-752-B in healthy adult volunteers.
- Conditions
- Hypertension
- Being tested
- Losartan (COZZAR®), Pitavastatin plus Ezetemibe
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan (COZZAR®)Drug
HUC2A-752-A
Pitavastatin plus EzetemibeDrug
HUC2A-752-B
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | HUC2A-752-A Receives: Drug: Losartan (COZZAR®) |
| Pitavastatin/Ezetimibe | Experimental | HUC2A-752-B Receives: Drug: Pitavastatin plus Ezetemibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau,ss
Area Under the Curve
Measured: Day 15
Cmax,ss
Maximum concentration at steady state
Measured: Day 15
Secondary outcomes (4)
Tmax,ss
Time to maximum concentration at steady state
Measured: Day 15
t1/2
Half-life
Measured: Day 15
CLss/F
Apparent Clearance
Measured: Day 15
Vdss/F
Apparent Volume of Distribution at Steady State
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784621
- Sponsor's protocol ID
- HUC2A-752-101
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple-oral Dosing, Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-Drug Interaction Between HUC2A-752-A and HUC2A-752-B in Healthy Adults
- ClinicalTrials.gov ID
- NCT07784621
- Acronym / sponsor ID
- HUC2A-752-101
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Aug 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.
This study evaluates the pharmacokinetic drug-drug interactions of repeated co-administration of HUC2A-752-A and HUC2A-752-B compared to monotherapy of each agent in healthy adults
Detailed description
This randomized, open-label, 2-arm, 2-period, multiple-dose, phase 1 clinical trial evaluates the safety, tolerability, and pharmacokinetics of HUC2A-752 following repeated oral administration of HUC2A-752-A and HUC2A-752-B in healthy adult volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: Losartan (COZZAR®)HUC2A-752-A |
| Pitavastatin/Ezetimibe | Experimental | Drug: Pitavastatin plus EzetemibeHUC2A-752-B |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult volunteers
- Individuals with a body weight between 50.0 kg and 90.0 kg and a BMI between 18.5 kg/m² and 29.9 kg/m²
Key exclusion criteria (3 listed)
- Individuals with a history or presence of clinically significant diseases of the following systems: hepatobiliary, renal, neurological, immunological, respiratory, gastrointestinal, endocrine, hematologic/oncologic, cardiovascular , musculoskeletal, urological, psychiatric, or sexual dysfunction.
- Individuals with a history of gastrointestinal diseases or gastrointestinal surgeries that could affect the safety or pharmacokinetic evaluation of the investigational product.
- Individuals with a history of hypersensitivity or clinically significant hypersensitivity reactions to losartan, pitavastatin, ezetimibe, angiotensin receptor blockers, statins, or any other medications.
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 |
|---|---|---|
| Losartan (COZZAR®)HUC2A-752-A | Drug | Losartan |
| Pitavastatin plus EzetemibeHUC2A-752-B | Drug | Pitavastatin/Ezetimibe |
Primary outcome
AUCtau,ss
Time frame: Day 15
Area Under the Curve
Cmax,ss
Time frame: Day 15
Maximum concentration at steady state
4 secondary outcomes
Tmax,ss
Time frame: Day 15
t1/2
Time frame: Day 15
CLss/F
Time frame: Day 15
Vdss/F
Time frame: Day 15
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 10 Sep 2026.
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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 Losartan (COZZAR®) and Pitavastatin plus Ezetemibe in people with Hypertension, run by Huons Co., Ltd. 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 3 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 10 Sep 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 Huons (+82-70-7492-6023, jywon@huons.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCtau,ss (time frame: Day 15). 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 10 Sep 2026.