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

Phase 1

Completed

• Conditions: Hyperlipidemias
• Interventions: Drug: AD-104-A

• Registration Number: NCT05703282
• Lead Sponsor: Addpharma Inc.

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

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-30
• Study Start: 2023-03-13
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Impairment 1	AD-104-A	Test Drug: AD-104-A
Renal Impairment 2	AD-104-A	Test Drug: AD-104-A
Renal Impairment 3	AD-104-A	Test Drug: AD-104-A
Normal	AD-104-A	Test Drug: AD-104-A

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of