Study to Evaluate the Safety and PK of UI018 | NCT05085184

Studies
Study to Evaluate the Safety and PK of UI018

NCT05085184

Sponsor

Korea United Pharm. Inc.

Status

Unknown status

Last Update Posted

Dec 21, 2021Actual

Enrollment

44Actual

Phase

Phase 1

Conditions

Hyperlipemia, Mixed

Interventions

administration of UI018
co-administration of UIC201806 and UIC201602

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2021Actual

Primary Completion Date

Nov 30, 2021Actual

Completion Date

Sep 5, 2022Estimated

First Submitted Date

Sep 27, 2021

First Submission Date that Met QC Criteria

Oct 7, 2021

First Posted Date

Oct 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2021

Last Update Posted Date

Dec 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UI018	Experimental		Drug: administration of UI018
UIC201806 and UIC201602	Active Comparator		Drug: co-administration of UIC201806 and UIC201602

Interventions

Name	Type	Description	Arm Group Labels	Other Names
administration of UI018	Drug	Test	UI018
co-administration of UIC201806 and UIC201602

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maximum concentration(Cmax)		0 to 96 hrs
area under the curve(AUC)		0 to 96 hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Injin Jang, Dr.	Seoul National University College of Medicine and Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Jongno-gu	110-744	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006954	Hyperlipoproteinemia Type V

Ancestor Terms

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided