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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2024-04-05

Brief Summary

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

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Detailed Description

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

Conditions

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Hyperlipidemias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Impairment 1

Test Drug: AD-104-A

Group Type EXPERIMENTAL

AD-104-A

Intervention Type DRUG

PO, Single-Dose, AD-104-A

Renal Impairment 2

Test Drug: AD-104-A

Group Type EXPERIMENTAL

AD-104-A

Intervention Type DRUG

PO, Single-Dose, AD-104-A

Renal Impairment 3

Test Drug: AD-104-A

Group Type EXPERIMENTAL

AD-104-A

Intervention Type DRUG

PO, Single-Dose, AD-104-A

Normal

Test Drug: AD-104-A

Group Type EXPERIMENTAL

AD-104-A

Intervention Type DRUG

PO, Single-Dose, AD-104-A

Interventions

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AD-104-A

PO, Single-Dose, AD-104-A

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes