A study to test the safety and efficacy of RBD1119 given by injection in participants with coronary artery disease

Korábbi kezelés

• Clinically significant acute illness within 7 days before the first dose of trial drug.
• Donation of >300 mL of blood within 56 days before the first dose of trial drug
• Receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before the first dose of the trial drug, or current participation in the follow-up phase of another clinical trial. Any prior use of advanced therapies (antisense oligonucleotide/small interfering ribonucleic acid (siRNA)/gene therapy/cell therapy) should be evaluated and judged by the Investigator.
• Use of dual antiplatelet therapy at the time of randomization
• Major surgery during the last 30 days before screening or planned major surgery or intervention within the trial period.
• New York Heart Association class III–IV heart failure at screening or randomization, hospitalization for exacerbation of chronic heart failure within the previous 12 months, or other indices of unstable heart failure
• Clinically significant arrhythmia associated with hemodynamic instability or impaired organ perfusion, unless adequately controlled with stable therapeutic management for at least 3 months prior to Screening

Más betegség

• Expected survival time < 1 year due to non-cardiac disorders
• History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc)
• History of severe intolerance to subcutaneous injection (minor reactions such as localized swelling or redness are permitted)
• Any underlying disease, or surgical or medical condition that, in the opinion of the Investigator, might interfere with the participant’s ability to comply with the protocol or with the interpretation of the clinical trial results.
• Evidence of active hepatitis B virus, hepatitis C virus (HCV), or HIV infection at screening
• Ischemia with non-obstructive coronary arteries/ Angina with non-obstructive coronary arteries vasospastic/microvascular angina or suspected CAD without objective evidence of obstructive atherosclerotic CAD at screening
• Any clinical suspicion of acute coronary syndrome or unstable angina at randomization according to ESC criteria
• Presence of ≥2 minor or ≥1 major bleeding risk criterion at screening

Laborértékek

• Liver chemistry abnormalities at Screening (central laboratory reference ranges)
• Documented left ventricular ejection fraction <30% at screening, based on available prior or current assessment

Egyéb

• Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post treatment period

• Male or female participants age ≥50 years. For male participants, those who are potent and sexually active with a female partner of childbearing potential must agree to use effective male contraception during the trial.. In addition, the female partner must use appropriate contraception during the trial and for at least 6 months after the participant’s last dose of trial treatment. Female participants must be post-menopausal or permanently sterile for at least 6 months before dosing.
• Stable, documented atherosclerotic CAD (ESC Chronic Coronary Syndromes): Asymptomatic or symptomatic CCS with objective documentation of atherosclerotic/obstructive CAD, and clinically stable
• Ongoing treatment with a low dose aspirin 75-100 mg for at least 30 days prior randomization
• Stable standard of care treatment (ie, ongoing since at least 30 days prior to randomization) that is intended to continue unchanged during the trial.