A Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282

NCT ID: NCT06858865

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-12

Study Completion Date

2025-08-14

Brief Summary

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Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.

Detailed Description

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The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-228A compared with coadministration AD-2281 and AD-2282 in healthy subjects.

Conditions

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Primary Hypercholesterolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

Period 1 : Reference Drug(AD-2281 and AD-2282), Period 2 : Test Drug(AD-228A)

Group Type EXPERIMENTAL

AD-228A

Intervention Type DRUG

AD-228A Oral Tablet

AD-2281 and AD-2282

Intervention Type DRUG

AD-2281 Oral Tablet + AD-2282 Oral Tablet

Sequence B

Period 1 : Test Drug(AD-228A), Period 2 : Reference Drug(AD-2281 and AD-2282)

Group Type EXPERIMENTAL

AD-228A

Intervention Type DRUG

AD-228A Oral Tablet

AD-2281 and AD-2282

Intervention Type DRUG

AD-2281 Oral Tablet + AD-2282 Oral Tablet

Interventions

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AD-228A

AD-228A Oral Tablet

Intervention Type DRUG

AD-2281 and AD-2282

AD-2281 Oral Tablet + AD-2282 Oral Tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H+ Yangji Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-228BE-02

Identifier Type: -

Identifier Source: org_study_id

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