Hyperlipemia, MixedPhase 1NCT05085184
Study to Evaluate the Safety and PK of UI018
A Phase 1 study testing administration of UI018 and co-administration of UIC201806 and UIC201602 in people with Hyperlipemia, Mixed, run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial summary
This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipemia, Mixed
- What is being tested?
- administration of UI018 and co-administration of UIC201806 and UIC201602
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Sep 2021to 5 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects between the ages of 19 and 45 years at screening
- Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal body Weight(IBW) [ IBW (kg) = (height(cm) - 100) x 0.9 ]
- Subjects able to read and understand a written informed consent, and willing to decide to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 110-744
About this study
Official title: A Randomized, Open, Single-dose, 2x2x4 Replicate Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of UIC201806 and UIC201602 or Administration of UI018 in Healthy Volunteers
This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.
- Conditions
- Hyperlipemia, Mixed
- Being tested
- administration of UI018, co-administration of UIC201806 and UIC201602
- Medical subject headings
- Hyperlipoproteinemia Type V
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of UI018Drug
Test
co-administration of UIC201806 and UIC201602Drug
Reference
| Study group | Role | What they receive |
|---|---|---|
| UI018 | Experimental | Not described Receives: Drug: administration of UI018 |
| UIC201806 and UIC201602 | Active comparator | Not described Receives: Drug: co-administration of UIC201806 and UIC201602 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum concentration(Cmax)
Measured: 0 to 96 hrs
area under the curve(AUC)
Measured: 0 to 96 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start6 Sep 2021
- Primary completion30 Nov 2021
- Study completion5 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipemia, MixedStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Injin Jang, Dr., Principal investigator, Seoul National University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085184
- Sponsor's protocol ID
- KUP-UI018-103
- Status last verified
- Dec 2021
- First submitted
- 27 Sep 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Single-dose, 2x2x4 Replicate Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of UIC201806 and UIC201602 or Administration of UI018 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05085184
- Acronym / sponsor ID
- KUP-UI018-103
- Conditions
- Hyperlipemia, Mixed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 5 Sep 2022 (estimated)
- First posted
- 20 Oct 2021 (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 is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI018 | Experimental | Drug: administration of UI018 |
| UIC201806 and UIC201602 | Active comparator | Drug: co-administration of UIC201806 and UIC201602 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects between the ages of 19 and 45 years at screening
- Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal body Weight(IBW) [ IBW (kg) = (height(cm) - 100) x 0.9 ]
- Subjects able to read and understand a written informed consent, and willing to decide to participate in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| administration of UI018Test | Drug | UI018 |
| co-administration of UIC201806 and UIC201602Reference | Drug | UIC201806 and UIC201602 |
Primary outcome
maximum concentration(Cmax)
Time frame: 0 to 96 hrs
area under the curve(AUC)
Time frame: 0 to 96 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Injin Jang, Dr. principal investigator
Seoul National University College of Medicine and Hospital
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 administration of UI018 and co-administration of UIC201806 and UIC201602 in people with Hyperlipemia, Mixed, run by Korea United Pharm. 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 0 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: status not confirmed, as of the sponsor's last update on 21 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum concentration(Cmax) (time frame: 0 to 96 hrs). 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 21 Dec 2021.