A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A

Phase 1

Recruiting

• Conditions: Mixed Dyslipidemia
• Interventions: Drug: PA-111; Drug: PA-111A

• Registration Number: NCT06932705
• Lead Sponsor: Addpharma Inc.

Brief Summary

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.

Detailed Description

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Body weight equal to or greater than 50kg (Female 45kg) and 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A (RT)	PA-111	Period 1: Reference (PA-111A), Period 2: Test (PA-111)
Sequence A (RT)	PA-111A	Period 1: Reference (PA-111A), Period 2: Test (PA-111)
Sequence A (TR)	PA-111	Period 1: Test (PA-111), Period 2: Reference (PA-111A),
Sequence A (TR)	PA-111A	Period 1: Test (PA-111), Period 2: Reference (PA-111A),

Primary Outcome Measures

Name	Time	Method
Maximum concentration of drug in plasma (Cmax)	pre-dose (0hour) to 72hours	Cmax of PA-111
Area under the plasma concentration-time curve during dosing interval (AUCt)	pre-dose (0hour) to 72hours	AUCt of PA-111

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of