Study to Evaluate the Safety and PK of UI018

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperlipemia, Mixed
• Intervention / Treatment: Drug: administration of UI018; Drug: co-administration of UIC201806 and UIC201602

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 110-744
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UI018	Drug: administration of UI018; Test
Active Comparator: UIC201806 and UIC201602	Drug: co-administration of UIC201806 and UIC201602; Reference

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Korea United Pharm. Inc.
• Investigators: Principal Investigator: Injin Jang, Dr., Seoul National University College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Anticipated): September 5, 2022

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypertriglyceridemia; Hyperlipidemias; Hyperlipoproteinemia Type V
• Other Study ID Numbers: KUP-UI018-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes