Stable Coronary Artery Disease CADPhase 2NCT06717074
A Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of RBD4059 in Participants With Stable Coronary Artery Disease
A Phase 2 study testing RBD4059 in people with Stable Coronary Artery Disease CAD, run by Ribocure Pharmaceuticals AB at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stable Coronary Artery Disease CAD
- What is being tested?
- RBD4059
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 28 Aug 2024to 29 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Main exclusion Criteria:
Show all 23Show fewer
- 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:
- Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history.
- Thromboembolic diseases.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Stable Coronary Artery Disease CAD
- Being tested
- RBD4059, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD4059Drug
RBD4059, active drug.
PlaceboDrug
Placebo that is identical in appearance and volume to the doses of active IMP.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group, active | Experimental | Participants will receive RBD4059 as subcutaneous injections Receives: Drug: RBD4059 |
| Low dose group, placebo | Placebo comparator | Participants will receive placebo as subcutaneous injections Receives: Drug: Placebo |
| High dose group, active | Experimental | Participants will receive RBD4059 as subcutaneous injections Receives: Drug: RBD4059 |
| High dose group, placebo | Placebo comparator | Participants will receive placebo as subcutaneous injections Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline until end of trial at week 48 or 60, depending on the dose group.
Secondary outcomes (5)
Plasma concentrations of RBD4059.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: From randomization until week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start28 Aug 2024
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Artery Disease CADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ribocure Pharmaceuticals AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717074
- Sponsor's protocol ID
- RC03T001
- Status last verified
- May 2026
- First submitted
- 4 Nov 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06717074
- Acronym / sponsor ID
- RC03T001
- Conditions
- Stable Coronary Artery Disease CAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ribocure Pharmaceuticals ABIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose group, active | Experimental | Drug: RBD4059Participants will receive RBD4059 as subcutaneous injections |
| Low dose group, placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo as subcutaneous injections |
| High dose group, active | Experimental | Drug: RBD4059Participants will receive RBD4059 as subcutaneous injections |
| High dose group, placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo as subcutaneous injections |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBD4059RBD4059, active drug. | Drug | High dose group, active, Low dose group, active |
| PlaceboPlacebo that is identical in appearance and volume to the doses of active IMP. | Drug | High dose group, placebo, Low dose group, placebo |
Primary outcome
Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest (AESIs) during the trial.
Time frame: From baseline until end of trial at week 48 or 60, depending on the dose group.
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).
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBD4059 in people with Stable Coronary Artery Disease CAD, run by Ribocure Pharmaceuticals AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest (AESIs) during the trial. (time frame: From baseline until end of trial at week 48 or 60, depending on the dose group.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.