A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AZD4144 |
Participants will receive oral dose of AZD4144 for 28 days. |
|
|
Placebo Comparator Placebo |
Participants will receive oral dose of Placebo for 28 days. |
|
Recruiting Locations
Glendale, California 91203
Daytona Beach, Florida 32117
Jacksonville, Florida 32216
Miami, Florida 33125
Port Orange, Florida 32127
Tampa, Florida 33603
Farmington Hills, Michigan 48334
Bronx, New York 10455
Sherman, Texas 75092
More Details
- NCT ID
- NCT06675175
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed Description
This is a Phase 1b, randomized, double blind, placebo-controlled study and will be conducted in participants with established ASCVD and CKD with persistent inflammation (High-sensitivity C-reactive protein [hsCRP] > 2 mg/L and eGlomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73m2). The participants will be randomized in the 1:1 ratio to either receive treatment with AZD4144 or placebo. The study will be comprised of: - A screening period of 28 days - Treatment period where each participant will either receive oral dose of AZD4144 or placebo for 28 days. - A follow-up visit (Day 35 ±1) and a Final Follow-up (on Day 56±1) post first dose administration. The total duration of the study will be approximately 12 weeks.