Stable Coronary Artery Disease
Conditions
Brief summary
Frequency, intensity and seriousness of the AEs during the trial as well as clinically significant changes in laboratory parameters, vital signs, physical examinations and 12-lead ECG at each visit from baseline to end of trial.
Detailed description
Plasma concentrations of RBD4059 will be summarised with descriptive statistics by sampling collection time point, Actual and percentage change from baseline in FXI activity and compared to placebo throughout the trial period, Proportion of participants with positive immunogenicity, measured as titers of anti-drug antibodies (ADAs), at each evaluation time point., Change from baseline in APTT and PK(INR) levels compared to placebo throughout the trial period, Change from baseline in platelet inhibition levels compared to placebo throughout the trial period.
Interventions
DRUGRBD4059 injection
DRUGThe corresponding placebo consist of the 25 mM phosphate buffer solution with 2 µg of vitamin b2 added for colouring purposes only
Sponsors
Ribocure Pharmaceuticals AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, intensity and seriousness of the AEs during the trial as well as clinically significant changes in laboratory parameters, vital signs, physical examinations and 12-lead ECG at each visit from baseline to end of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of RBD4059 will be summarised with descriptive statistics by sampling collection time point, Actual and percentage change from baseline in FXI activity and compared to placebo throughout the trial period, Proportion of participants with positive immunogenicity, measured as titers of anti-drug antibodies (ADAs), at each evaluation time point., Change from baseline in APTT and PK(INR) levels compared to placebo throughout the trial period, Change from baseline in platelet inhibition levels compared to placebo throughout the trial period. | — |
Countries
Sweden
Outcome results
None listed