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

INTERVENTION: Product Name: The corresponding placebo consist of the 25 mm phosphate buffer solution with 2 µg of vitamin b2 added for colouring purposes only, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: RBD1119 injection, Product Code:PRD13677474, Pharmaceutical Form: INJECTION, Other descriptive name: , Strength: CONDITION: Coronary artery disease ; MedDRA version: 20.0Level: PTClassification code: 10011078Term: Coronary artery disease Class: 100000004849 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To evaluate the pharmacodynamic effect of RBD1119 at three dose levels on coagulation factor XI activity at Week 8. Primary end point(s): Percentage change from baseline in coagulation factor XI activity at Week 8, compared with placebo. Secondary Objective: To evaluate the safety of RBD1119 at three dose levels., To assess the plasma exposure (pharmacokinetics [PK]) of RBD1119., To evaluate the effect of RBD1119 on biomarkers including activated partial thromboplastin time (aPTT), prothrombin time/international normalized ratio (PT/INR), and coagulation factor XI antigen levels. SECONDARY OUTCOME: Secondary end point(s):1. Frequency, intensity, and seriousness of AEs during the trial, as well as clinically significant changes in laboratory parameters, vital signs, physical examinations, and 12‐lead ECGs Secondary end point(s):2. Plasma concentrations of RBD1119, summarized with descriptive statistics by dose and sampling timepoint Secondary end point(s):3. Change from baseline and percentage change from baseline in coagulation factor XI activity after dosing of RBD1119, compared with placebo, over the trial period Secondary end point(s):4. Change from baseline and percentage change from baseline in aPTT, PT/INR and coagulation factor XI antigen levels after dosing of RBD1119, compared with placebo, over the trial period. INCLUSION CRITERIA: 1. 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., 2. Stable, documented atherosclerotic CAD (ESC Chronic Coronary Syndromes): Asymptomatic or symptomatic CCS with objective documentation of atherosclerotic/obstructive CAD, and clinically stable, 3. Ongoing treatment with a low dose aspirin 75‐100 mg for at least 30 days prior randomization, 4. Stable standard of care treatment (ie, ongoing since at least 30 days prior to randomization) that is intended to continue unchanged during the trial.