A Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Repeated Subcutaneously Administered RBD4059 in Participants with Stable Coronary Artery Disease

Trial details

Who runs it

Ribocure Pharmaceuticals AB

Trial code

EU 2023-510370-14-00

Record updated

2025. december 12.

Original description

To evaluate the safety of RBD4059 compared to placebo when administered subcutaneously as repeated doses in participants with stable CAD that are under treatment with low dose aspirin (75 mg)Read full original descriptionShow less

To evaluate the safety of RBD4059 compared to placebo when administered subcutaneously as repeated doses in participants with stable CAD that are under treatment with low dose aspirin (75 mg)

Inclusion: Willing and able to give written informed consent for participation in the trial; Male or female (post-menopausal) participants ≥50-75 years; Patients with stable CAD defined as chronic coronary syndromes according to ESCs guideline on chronic coronary syndromes including the category asymptomatic or symptomatic patients >1 year after initial diagnosis or revascularization; Ongoing standard treatment with aspirin 75 mg for at least 3 months; Stable prescription drugs i.e., ongoing since at least 30 days prior to randomization, should continue during the trial.

Exclusion: Any clinical suspicion on acute coronary syndrome or unstable angina at enrolment according to ESC criteria : (i) rest angina, i.e. pain of characteristic nature and location occurring at rest and for prolonged periods (>20 min); (ii) new-onset angina, i.e. recent (2 months) onset of moderate-to-severe angina (Canadian Cardiovascular Society grade II or III); or (iii) crescendo angina, i.e. previous angina, which progressively increases in severity and intensity, and at a lower threshold, over a short period of time; Clinically significant acute illness within 7 days before the first dose of trial drug; Consume more than 8 (female) or 14 (male) units of alcohol per week (1 standard unit of alcohol contains 14 g of alcohol and corresponds to, e.g., 360 mL of beer, 150 mL of wine, or 45 mL of spirits at 40% alcohol content.) within 6 months before screening or positive screen for alcohol abuse or clinical evidence of other drug abuse within 12 months; Donated more than 300 mL of blood within 56 days before the first dose of trial drug; Major surgery during last 30 days or planned major surgery or intervention within trial period; Elective PCIor CABG within the previous 12 months; Previously confirmed ischemic stroke; Received an investigational product within 30 days or 5 half-lives (whichever is longer) before the first dose of the study drug or are in the follow-up of another clinical study. If subjects used advanced therapy (ASO/siRNA/gene therapy/cell therapy), it should be judged by the investigator; New York Heart Association (NYHA) class III-IV heart failure at entry, hospitalization for exacerbation of chronic heart failure within the previous 12 months or other indices of unstable heart failure; Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCVAb), HIV antibody (HIVAb) at screening; History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc); Patients with other clinical scenarios qualifying in the ESC definition of chronic coronary syndromes: patients with suspected CAD and ‘stable’ anginal symptoms, and/or dyspnoea, with new onset of heart failure (HF) or left ventricular (LV) dysfunction and suspected CAD, with angina and suspected vasospastic or microvascular disease; Ongoing indication for chronic anti-coagulation therapy (incl. but not limited to patients with: atrial fibrillation, venous thrombo-embolism, mechanical cardiac valves) with NOACs, warfarin or other similar anticoagulants; History of severe intolerance to subcutaneous (SC) injection (minor reactions are permitted, e.g. localised swelling or redness.); Hemodynamically significant valvular disease or valvular disease likely to require surgery within 3 years; Expected survival time is less than one year for non-cardiac related disorders; History or presence of: a. Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history. b. Thromboembolic diseases; An underlying known disease, or surgical or medical condition that, in the opinion of the Investigator, might interfere with the participants ability to comply with the protocol or the interpretation of the clinical trial results; AST, ALP, or GGT > ULN (as per the local laboratory reference range), and considered clinically significant by the Investigator; Left ventricular ejection fraction (LVEF) < 30% at enrolment; Capillary Hb <120 g/l for women and <130 g/L for men; Creatinine clearance calculated by Cockcroft Gault equation <60ml/min*m2 at the time of enrolment. Hemodynamically significant valvular disease or valvular disease likely to require surgery within 3 years; Alanine aminotransferase (ALT) and/or total bilirubin >1.5 the upper limit of normal (ULN) (as per the local laboratory reference range); No repeat assessments are allowed; High bleeding risk defined as history of any significant bleeding (included but not limited to intracerebral haemorrhage and gastrointestinal), anaemia, liver failure, age >75 years or Clinical Frailty Score [2] > 5, or weight <60kg; Presence of any significant arrythmia in opinion of the investigator.

EU CTIS 2023-510370-14-00