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

Addpharma

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemias

Treatments: Drug: AD-104-A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05703282

AD-104PK_N

Details and patient eligibility

About

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

Full 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

Enrollment: 32 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Renal Impairment 1

Experimental group

Description:

Test Drug: AD-104-A

Treatment:

Drug: AD-104-A

Renal Impairment 2

Experimental group

Description:

Test Drug: AD-104-A

Treatment:

Drug: AD-104-A

Renal Impairment 3

Experimental group

Description:

Test Drug: AD-104-A

Treatment:

Drug: AD-104-A

Normal

Experimental group

Description:

Test Drug: AD-104-A

Treatment:

Drug: AD-104-A