NCT05085184

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

September 27, 2021

Last Update Submit

December 20, 2021

Conditions

Hyperlipemia, Mixed

Outcome Measures

Primary Outcomes (2)

  • maximum concentration(Cmax)

    0 to 96 hrs

  • area under the curve(AUC)

    0 to 96 hrs

Study Arms (2)

UI018

EXPERIMENTAL
Drug: administration of UI018

UIC201806 and UIC201602

ACTIVE COMPARATOR
Drug: co-administration of UIC201806 and UIC201602

Interventions

administration of UI018DRUG

Test

UI018
co-administration of UIC201806 and UIC201602DRUG

Reference

UIC201806 and UIC201602

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type V

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypertriglyceridemia

Study Officials

  • Injin Jang, Dr.

    Seoul National University College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 20, 2021

Study Start

September 6, 2021

Primary Completion

November 30, 2021

Study Completion

September 5, 2022

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations

KR(1)