A Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of RBD4059 in Participants With Stable Coronary Artery Disease

NCT06717074 | Active Not Recruiting Phase 2

• 1 other identifier: RC03T001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the safety of drug RBD4059, and also if drug RBD4059 works to treat stable coronary artery disease in adults. The main questions the trial aim to answer are: What medical problems may participants experience when taking drug RBD4059? Researchers will compare drug RBD4059 to a placebo to see if drug RBD4059 works to treat stable coronary artery disease. Participants will: Receive drug RBD4059 or a placebo. Visit the clinic 11 or 12 times during 11 or 14 months for checkups and tests, depending on which treatment group they belong to.

Conditions

Stable Coronary Artery Disease CAD

Outcome Measures

Primary Outcomes (1)

• Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest (AESIs) during the trial.

  Number and percentage of participants with AEs, SAEs and AEs of interest. All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).

  From baseline until end of trial at week 48 or 60, depending on the dose group.

Secondary Outcomes (5)

• Plasma concentrations of RBD4059.

  In conjunction of administration of the IMP

• Change and percent change compared with pre-dose baseline of FXI activity at different time points in each group.

  From baseline until end of trial at week 48 or 60, depending on the dose group.

• Proportion of participants with positive immunogenicity, measured as plasma concentrations of anti-drug antibodies (ADAs)

  From randomization until end of trial at week 48 or 60, depending on the dose group.

• Change and percent change compared with pre-dose baseline of APTT and PK(INR) at different time points in each group.

  From baseline until end of trial at week 48 or 60, depending on the dose group.

• Change and percent change compared with pre-dose baseline of platelet inhibition at different time points in each group.

  From randomization until week 48

Study Arms (4)

Low dose group, active

EXPERIMENTAL

Participants will receive RBD4059 as subcutaneous injections

Drug: RBD4059

Low dose group, placebo

PLACEBO COMPARATOR

Participants will receive placebo as subcutaneous injections

Drug: Placebo

High dose group, active

EXPERIMENTAL

Participants will receive RBD4059 as subcutaneous injections

Drug: RBD4059

High dose group, placebo

PLACEBO COMPARATOR

Participants will receive placebo as subcutaneous injections

Drug: Placebo

Interventions

RBD4059 DRUG

RBD4059, active drug.

High dose group, active; Low dose group, active

Placebo DRUG

Placebo that is identical in appearance and volume to the doses of active IMP.

High dose group, placebo; Low dose group, placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 more than 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.

You may not qualify if:

• Presence of any significant arrythmia in opinion of the investigator
• 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 (more than 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.
• 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.
• High bleeding risk defined as history of any significant bleeding (included but not limited to intracerebral haemorrhage and gastrointestinal), anaemia, liver failure, age more than 75 years or Clinical Frailty Score more than 5, or weight less than 60kg.
• Major surgery during last 30 days or planned major surgery or intervention within trial period.
• Capillary Hb less than 120 g/l for women and less than 130 g/L for men.
• Elective PCIor CABG within the previous 12 months.
• Previously confirmed ischemic stroke.
• 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.
• Left ventricular ejection fraction (LVEF) less than 30% at enrolment.
• 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.
• Creatinine clearance calculated by Cockcroft Gault equation less than 60ml/min\*m2 at the time of enrolment. Hemodynamically significant valvular disease or valvular disease likely to require surgery within 3 years.
• 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:

Sponsors & Collaborators

• Ribocure Pharmaceuticals AB: lead

Study Sites (1)

Ribocure Clinic

Mölndal, 43153, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 4, 2024
• Study Start: August 28, 2024
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-09

Locations

SE (1)