NCT07784621

Brief 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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
4mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 5, 2026

Last Update Submit

August 20, 2026

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • AUCtau,ss

    Area Under the Curve

    Day 22

  • Cmax,ss

    Maximum concentration at steady state

    Day 22

Secondary Outcomes (4)

  • Tmax,ss

    Day 22

  • t1/2

    Day 22

  • CLss/F

    Day 22

  • Vdss/F

    Day 22

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Losartan (COZZAR®)

Arm 2

EXPERIMENTAL
Drug: Pitavastatin plus Ezetemibe

Interventions

Losartan (COZZAR®)DRUG

HUC2A-752-A

Arm 1
Pitavastatin plus EzetemibeDRUG

HUC2A-752-B

Arm 2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Losartanpitavastatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Central Study Contacts

Huons

CONTACT

+82-70-7492-6023jywon@huons.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 25, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Locations

KR(1)