A Parallel, Open-Label, Single-Dose Administration, Phase 1 Clinical Study to Assess the Safety and Pharmacokinetics of AD-104-A in Healthy Adult Volunteers and Patients With Renal Impairment

Addpharma Inc.1 site in 1 country32 target enrollmentMarch 13, 2023

ConditionsHyperlipidemias

InterventionsAD-104-A

Overview

Phase: Phase 1
Intervention: AD-104-A
Conditions: Hyperlipidemias
Sponsor: Addpharma Inc.
Enrollment: 32
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-104-A

Detailed Description

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-104-A in Healthy Adult Volunteers and Patients with Renal Impairment

Registry

clinicaltrials.gov

Start Date

March 13, 2023

End Date

April 5, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Addpharma Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For all subjects
•Adults aged 19 years and older
•Body mass index(BMI) of 18 to 30 kg/m2
•Voluntarily given written informed consent
•For renal Impairment subjects
•30 ≤ eGFR \< 90 mL/min/1.73m\^2
•For healthy subjects
•eGFR ≥ 90 mL/min/1.73m\^2

Exclusion Criteria

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