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NCT Number: NCT07784621

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

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

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Losartan (COZZAR®)

Drug

HUC2A-752-A

Pitavastatin plus Ezetemibe

Drug

HUC2A-752-B

Primary outcomes

  1. AUCtau,ss

    Time frame: Day 22

    Area Under the Curve

  2. Cmax,ss

    Time frame: Day 22

    Maximum concentration at steady state

Secondary outcomes

  1. Tmax,ss

    Time frame: Day 22

    Time to maximum concentration at steady state

  2. t1/2

    Time frame: Day 22

    Half-life

  3. CLss/F

    Time frame: Day 22

    Apparent Clearance

  4. Vdss/F

    Time frame: Day 22

    Apparent Volume of Distribution at Steady State

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study title

An Open-Label, Multiple-oral Dosing, Fixed-Sequence 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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