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

Last updated: April 10, 2025
Sponsor: Addpharma Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

PA-111

PA-111A

Clinical Study ID

NCT06932705
PA-111BE
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 screeningvisit

Exclusion

Exclusion Criteria:

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

  • Other exclusions applied

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: PA-111
Phase: 1
Study Start date:
April 01, 2025
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • H Plus Yangji Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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