NCT06717074

A Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of RBD4059 in Participants With Stable Coronary Artery Disease

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ribocure Pharmaceuticals AB · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Stable Coronary Artery Disease CAD

Interventions

Type	Name	Description
DRUG	RBD4059	RBD4059, active drug.
DRUG	Placebo	Placebo that is identical in appearance and volume to the doses of active IMP.

Timeline

• Start date: 2024-08-28
• Primary completion: 2026-04-28
• Completion: 2026-04-28
• First posted: 2024-12-04
• Last updated: 2026-03-11

Locations

1 site across 1 country: Sweden