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Safety and Pharmacodynamic Study of Subcutaneous RBD1119 in Adults with Coronary Artery Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on individuals with Coronary artery disease, a condition where the arteries that bring blood to the heart become narrowed or blocked. The investigational medicine, called RBD1119, is administered by a subcutaneous injection (a small shot given under the skin). Some participants will receive a harmless placebo instead of the active drug. The primary purpose is to determine whether the medicine changes the activity of a blood‑clotting protein known as coagulation factor XI after eight weeks of treatment.

Participants will be randomly assigned to receive either the study drug at one of three dose levels or the placebo, and neither the participants nor the study staff will know which treatment is given. Over the course of several weeks, blood samples will be taken to assess clotting using tests such as aPTT (a test that measures how quickly blood forms a clot) and PT/INR (another test that evaluates clotting time). Heart health will be checked with a 12-lead ECG (a recording of the heart’s electrical activity). Safety will be monitored by recording any side effects, reviewing laboratory results, vital signs, and physical examinations.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
You attend the first study visit after being accepted into the trial. study staff explain the purpose of the research, the procedures, and potential risks. you sign a consent form to confirm that you understand and agree to participate.
Baseline measurements are taken, including a review of your medical history, a physical examination, vital signs such as blood pressure and heart rate, a 12‑lead electrocardiogram (ecg) which records the electrical activity of the heart, and blood samples to assess your current health status.
Step 2
Randomization to study medication
After baseline assessments, you are randomly assigned to receive either the investigational drug rbd1119 or a placebo. random assignment means that neither you nor the study staff know which product you receive, helping to keep the results unbiased.
Step 3
First injection
You receive a single subcutaneous injection, which means the medication is placed just under the skin using a small needle. the investigational product contains rbd1119 sodium at a dose of 000 milligram(s) per injection. the placebo consists of a 25 mm phosphate buffer solution with 2 µg of vitamin b2 added only for coloring.
The injection is administered by trained study personnel according to the study schedule.
Step 4
Regular follow‑up visits
You return to the study site at scheduled intervals for safety checks. during each visit, vital signs are recorded, a brief physical examination is performed, and blood samples are drawn.
The blood samples are used to measure the amount of rbd1119 in your plasma, to assess the activity of coagulation factor xi (a protein that helps blood clot), and to monitor other laboratory values such as aptt (activated partial thromboplastin time) and pt/inr (tests that evaluate blood clotting).
Any side effects or adverse events you experience are reported and evaluated.
Step 5
Week 8 primary assessment
At the eight‑week visit, a blood sample is taken to determine the percentage change from your baseline in coagulation factor xi activity. this measurement is the primary outcome of the trial and is compared with results from participants who received the placebo.
Step 6
Final study visit and discontinuation
After the week‑8 assessment, you complete a final study visit that includes a repeat physical examination, vital signs, ecg, and laboratory tests to ensure your health is stable.
The study medication is stopped, and you receive information about any further follow‑up that may be recommended by your own healthcare provider.

Who can join the trial?

5 criteria

You must be 50 years old or older and can be either male or female.
If you are a man who can have children and have a partner who could become pregnant, you must use reliable birth control during the study, and your partner must also use birth control during the study and for at least 6 months after your last dose. Women must be post‑menopausal (no periods for at least 12 months) or permanently unable to have children for at least 6 months before starting the study.
You need to have stable, documented coronary artery disease (narrowing of the heart’s blood vessels) that has been confirmed by a doctor and is not getting worse.
You must have been taking a low dose aspirin (75‑100 mg each day) for at least 30 days before joining the study.
You must be on regular heart‑related medicines that you have been taking for at least 30 days before the study and plan to keep taking the same doses while you are in the study (standard of care treatment).

Who cannot join the trial?

18 criteria

Women who are pregnant, breastfeeding, or planning to become pregnant during the study or shortly after cannot join.
People with abnormal liver chemistry test results (blood tests that show the liver is not working normally) at the screening visit are excluded.
Anyone whose doctor expects they will live less than one year because of a serious illness that is not related to the heart is not eligible.
A serious acute illness (a sudden severe disease) that occurred within the 7 days before the first dose disqualifies a participant.
Donating more than 300 mL of blood (about one pint) within the 56 days before the first dose makes a person ineligible.
People with a history of multiple drug allergies or an allergic reaction to an oligonucleotide or to N‑acetylgalactosamine (GalNAc) cannot take part.
Anyone who has had a severe intolerance to a subcutaneous injection (a shot given under the skin) is excluded; minor swelling or redness is allowed.
Receiving any investigational product (experimental drug) within 30 days or five half‑lives (whichever is longer) before the first dose, or currently being followed up in another trial, leads to exclusion. Prior use of advanced therapies such as antisense oligonucleotides, siRNA, gene therapy, or cell therapy must be reviewed by the investigator.
Any underlying disease, surgery, or medical condition that the doctor believes could interfere with following the study plan or affect the study results results in exclusion.
Evidence of active hepatitis B, hepatitis C, or HIV infection at screening disqualifies a participant.
Having ischemia (reduced blood flow to the heart) or angina (chest pain) with non‑obstructive coronary arteries, or suspected coronary artery disease without clear evidence of blocked arteries, excludes a person.
Any suspicion of acute coronary syndrome or unstable angina at randomization, according to European Society of Cardiology (ESC) criteria, makes a participant ineligible.
Having two or more minor or at least one major bleeding risk factor at screening leads to exclusion.
Using dual antiplatelet therapy (two medicines that prevent blood clots) at the time of randomization disqualifies a participant.
Having undergone major surgery in the 30 days before screening, or planning major surgery or a major medical procedure during the trial period, results in exclusion.
Having heart failure classified as New York Heart Association (NYHA) class III–IV, a hospitalization for worsening chronic heart failure in the past 12 months, or other signs of unstable heart failure makes a person ineligible.
Having a documented left ventricular ejection fraction (the percentage of blood the main heart chamber pumps out) of less than 30% at screening excludes a participant.
Having a significant arrhythmia (irregular heartbeat) that causes hemodynamic instability (unstable blood pressure or flow) or poor organ perfusion, unless it has been well‑controlled with stable treatment for at least 3 months before screening, leads to exclusion.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CTC Clinical Trial Consultants AB
Verified
Uppsala, Sweden
Region Skane Skanes Universitetssjukhus
Verified
Lund, Sweden
Ribocure Pharmaceuticals AB
Verified
Molndal, Sweden

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Investigated drugs

RBD1119 is an experimental medication given as a subcutaneous injection. In this study, participants receive multiple injections under the skin to see how the drug affects the activity of a blood clotting protein called factor XI. The trial is looking at whether RBD1119 can safely change this clotting activity over several weeks in people who have coronary artery disease. The medication is being tested at different dose levels to find the best amount that works without causing problems.

What is already known about the treatment

RBD1119 injection - This investigational drug is given as a subcutaneous injection, meaning a small needle is placed just under the skin. It is currently being studied in Phase II clinical trials and is not yet approved for regular medical use. The medication is aimed at people with coronary artery disease by lowering the activity of coagulation factor XI, which helps reduce unwanted blood clots. It works by attaching to factor XI and blocking its role in the clotting process, classifying it as a factor XI inhibitor, a type of anticoagulant.

Investigated diseases

Coronary artery disease - A condition where fatty deposits build up in the walls of the arteries that supply blood to the heart. Over time these deposits can narrow the vessels and limit the amount of blood that reaches heart muscle. The reduced blood flow may cause episodes of chest discomfort, especially during physical activity or stress. As the narrowing worsens, the heart may receive less oxygen even at rest. The disease typically develops slowly and can become more extensive if risk factors such as high cholesterol, smoking, or high blood pressure are not managed.