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A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-Drug Interaction Between HUC2A-752-A and HUC2A-752-B in Healthy Adults

An Open-Label, Multiple-oral Dosing, Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-Drug Interaction Between HUC2A-752-A and HUC2A-752-B in Healthy Adults

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07784621
Enrollment
30
Registered
2026-08-25
Start date
2026-10-01
Completion date
2027-02-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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

Detailed description

This randomized, open-label, 2-arm, 2-period, multiple-dose, phase 1 clinical trial evaluates the safety, tolerability, and pharmacokinetics of HUC2A-752 following repeated oral administration of HUC2A-752-A and HUC2A-752-B in healthy adult volunteers.

Interventions

Sponsors

Huons Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
AUCtau,ssDay 15Area Under the Curve
Cmax,ssDay 15Maximum concentration at steady state

Secondary

MeasureTime frameDescription
Tmax,ssDay 15Time to maximum concentration at steady state
t1/2Day 15Half-life
CLss/FDay 15Apparent Clearance
Vdss/FDay 15Apparent Volume of Distribution at Steady State

Countries

South Korea

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026