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

Addpharma

Status and phase: Completed; Phase 1

Conditions: Primary Hypercholesterolaemia

Treatments: Drug: AD-228A; Drug: AD-2281 and AD-2282

Study type: Interventional

Funder types: Industry

Identifiers

NCT06858865

AD-228BE-02

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Sequence A

Experimental group

Description:

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

Treatment:

Drug: AD-2281 and AD-2282

Drug: AD-228A

Sequence B

Experimental group

Description:

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

Treatment:

Drug: AD-2281 and AD-2282

Drug: AD-228A