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.
Low-dose group The trial will start with the low-dose group. The screening period takes place between D-28 to D-1 including informed consent, and those who meet the inclusion criteria and not meet any exclusion criteria will return to the trial site for further evaluating at D1 to confirm enrolment in the trial. Participants will be assigned and randomized to receive RBD4059 (n=10) or placebo (n=5). All participants will be dosed at the trial site and undergo blood sampling and examinations at pre-defined timepoints. A SRC meeting will be conducted on data from day 36 (W5), including at least 9 participants in the low-dose group. Provided acceptable safety profile of the low dose group, data from this SRC meeting will be used to guide initiation of the high-dose group. Participants will return to the site and be monitored for safety and efficacy throughout the trial. Safety will be monitored until D336 (Week 48). High-dose group This group will be initiated when the 36-day SRC meeting of the low-dose dose cohort has been conducted with no significant safety issues established. For the high-dose group, the screening period takes place between D-28 to D-1 including informed consent, and those who meet the inclusion criteria and not meet any exclusion criteria will return to the trial site for further evaluating at D1 to confirm enrolment in the trial. Participants will be assigned and randomized to receive RBD4059 (n=10) or placebo (n=5). All participants will be dosed at the trial site and undergo blood sampling at pre-defined timepoints. Participants will return to the site and be monitored for safety and efficacy throughout the trial until D426 (Week 60). In both treatment groups, a switch from treatment with aspirin 75 mg to the equivalent AMP (Trombyl 75 mg) will be initiated on D1 and continue to the end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Ribocure Clinic
Mölndal, Sweden
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).
Time frame: From baseline until end of trial at week 48 or 60, depending on the dose group.
Plasma concentrations of RBD4059.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: From randomization until week 48
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