NCT05703282

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

January 18, 2023

Last Update Submit

July 30, 2024

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (2)

  • Cmax

    To assess the Cmax of AD-104-A

    pre-dose to 192 hours

  • AUC

    To assess the AUC of AD-104-A

    pre-dose to 192 hours

Study Arms (4)

Renal Impairment 1

EXPERIMENTAL

Test Drug: AD-104-A

Drug: AD-104-A

Renal Impairment 2

EXPERIMENTAL

Test Drug: AD-104-A

Drug: AD-104-A

Renal Impairment 3

EXPERIMENTAL

Test Drug: AD-104-A

Drug: AD-104-A

Normal

EXPERIMENTAL

Test Drug: AD-104-A

Drug: AD-104-A

Interventions

AD-104-ADRUG

PO, Single-Dose, AD-104-A

NormalRenal Impairment 1Renal Impairment 2Renal Impairment 3

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • ≤ eGFR \< 90 mL/min/1.73m\^2
  • For healthy subjects
  • eGFR ≥ 90 mL/min/1.73m\^2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 30, 2023

Study Start

March 13, 2023

Primary Completion

April 5, 2024

Study Completion

April 5, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations

KR(1)