NCT06976489

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 9, 2025

Last Update Submit

May 9, 2025

Conditions

Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of PA-111

    pre-dose (0hour) to 72hours

  • Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt of PA-111

    pre-dose (0hour) to 72hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: Fasted, Period 2: Fed

Drug: PA-111

Sequence B

EXPERIMENTAL

Period 1: Fed, Period 2: Fasted

Drug: PA-111

Interventions

PA-111DRUG

PA-111 1Tab., Per Oral

Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus Yangji Hospital

Seoul, South Korea

Location

Central Study Contacts

JeongEun Park

CONTACT

+82-31-891-6989parkje@addpharma.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 16, 2025

Study Start

May 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)