A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.

Description

The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).

Conditions

Chronic Kidney Disease, Atherosclerotic Cardiovascular Disease

Study Overview

Study Details

Study overview

The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease

A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.

Condition
Chronic Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Glendale

Research Site, Glendale, California, United States, 91203

Daytona Beach

Research Site, Daytona Beach, Florida, United States, 32117

Jacksonville

Research Site, Jacksonville, Florida, United States, 32216

Miami

Research Site, Miami, Florida, United States, 33125

Port Orange

Research Site, Port Orange, Florida, United States, 32127

Tampa

Research Site, Tampa, Florida, United States, 33603

Farmington Hills

Research Site, Farmington Hills, Michigan, United States, 48334

Bronx

Research Site, Bronx, New York, United States, 10455

Sherman

Research Site, Sherman, Texas, United States, 75092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants with established ASCVD history of one or more of the following
  • 1. Prior Myocardial infarction (MI) (\>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
  • 2. Prior ischemic stroke (\>60 days from index event)
  • 3. Symptomatic Peripheral Arterial Disease
  • * Chronic kidney disease defined as eGlomular filtration rate (eGFR) ≥ 30 to \< 60 mL/min/1.73 m2
  • * Serum hsCRP \> 2 mg/L
  • * Body mass index ≥ 18 to ≤ 45 kg/m2
  • * All females must have a negative pregnancy test at the Screening Visit and at the randomization visit
  • 1. Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
  • 2. Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
  • 3. Females of non-childbearing potential must be confirmed at the Screening visit
  • * History of malignancy within the last 5 years
  • * History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
  • * Active systemic infection within 30 days
  • * Clinically significant active and chronic infections within 60 days prior to randomization
  • * Clinically significant recurrent infection (≥ 2× during the last 12-month period).
  • * Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury in the past 12 month

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2025-08-21