A Study to Assess the Safety and Pharmacokinetics of AD-104-A

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05703282

Enrollment

Registered

2023-01-30

Start date

2023-03-13

Completion date

2024-04-05

Last updated

2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemias

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

Interventions

DRUGAD-104-A

PO, Single-Dose, AD-104-A

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Cmax	pre-dose to 192 hours	To assess the Cmax of AD-104-A
AUC	pre-dose to 192 hours	To assess the AUC of AD-104-A

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026