In short
RBD1119 sodium is an investigational substance being studied in a Phase 2 clinical trial for people with coronary artery disease. The trial is authorised and plans to enrol 200 participants. It will test the safety and efficacy of RBD1119 given by injection under the skin, measuring its effect on coagulation factor XI activity at Week 8.
Key points
- RBD1119 sodium is an investigational substance with no marketing authorisation in these records.
- The only registered trial is a Phase 2 study in coronary artery disease.
- The trial has an authorised status and plans to enrol 200 participants.
- Participants receive RBD1119 by subcutaneous injection at three dose levels.
- The main measure is the percentage change in coagulation factor XI activity at Week 8 compared with placebo.
What is RBD1119 sodium?
RBD1119 sodium is an investigational substance currently being studied in a clinical trial for coronary artery disease. The registry records do not indicate that RBD1119 sodium is an authorised medicine; it appears to be in the research stage. The substance is listed under the name RBD1119 sodium, and the trial record describes it as a drug given by injection. No other names, development codes or trade names appear in the available data.
How does RBD1119 sodium work?
The trial record states that the main measurement is the percentage change from baseline in coagulation factor XI activity at Week 8 compared with placebo. This suggests that RBD1119 sodium is intended to affect coagulation factor XI, a protein involved in blood clotting. The trial is designed to evaluate the pharmacodynamic effect of RBD1119 at three dose levels on coagulation factor XI activity. No further details on the mechanism of action are provided in the registry data.
Which conditions is it studied for?
- Coronary artery disease — a condition in which the blood vessels supplying the heart become narrowed or blocked, reducing blood flow to the heart muscle. The authorised Phase 2 trial is investigating RBD1119 sodium in this condition.
How is RBD1119 sodium given?
RBD1119 sodium is given by subcutaneous injection, meaning it is injected under the skin. The trial record lists the intervention as "RBD1119 injection (000 mg milligram(s), SUBCUTANEOUS INJECTION)". The dose is not reported in the register, so no specific dose information is available. The trial includes three dose levels, but the exact amounts are not stated in the registry data.
What do the clinical trials show?
There is one registered clinical trial for RBD1119 sodium. It is a Phase 2, interventional study in coronary artery disease. The trial is authorised, meaning it has received approval to proceed. It plans to enrol 200 participants. The trial is designed to test the safety and efficacy of RBD1119 at three dose levels. The primary outcome is the percentage change from baseline in coagulation factor XI activity at Week 8, compared with placebo. The comparison arm receives a placebo consisting of a 25 mm phosphate buffer solution with 2 µg of vitamin B2 added for colouring purposes only. The study will evaluate the pharmacodynamic effect of RBD1119 on coagulation factor XI activity.
What side effects are known?
No information on side effects is available from the registry data for RBD1119 sodium. The trial is designed to assess safety, but no adverse event data have been reported in the trial record.