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

Korábbi kezelés

• History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
• Clinically significant active and chronic infections within 60 days prior to randomization

Más betegség

• History of malignancy within the last 5 years
• Active systemic infection within 30 days
• 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

• Participants with established ASCVD history of one or more of the following
  • Prior Myocardial infarction (MI) (>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
  • Prior ischemic stroke (>60 days from index event)
  • 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
  • Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
  • Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
  • Females of non-childbearing potential must be confirmed at the Screening visit