A Clinical Candidate for the Treatment of Rheumatoid Arthritis

Purpose and goal

The aim and goal of the entire project was to chemically refine a drug candidate for RA, carry out toxicological cell tests on this substance, preclinical animal studies, and to develop a method of administering the substance in the knee joint (synovial membrane) on healthy volunteers and measuring changes on different biomarkers for inflammation. The cell tests showed that the substance had a low effect and that toxic metabolites were formed. The method study was carried out successfully, the method was safe and tolerable and that biomarkers could follow in the knee joint.

Expected results and effects

Results (methodology study) Four out of 6 subjects consistently show lactate levels above 0.2 mmol / L throughout the microdialysis period. It occurred no significant changes from baseline over time in any of the analytes (lactate, glucose, pyruvate, glycerol) measured. The method detected measurable levels of all analytes (lactate, glucose, pyruvate, glycerol) in the synovial membrane at the knee of all subjects. Five AEs was reported in the study, 2 of which were assessed related to the procedure. The procedure was safe and well tolerated.

Planned approach and implementation

Healthy voluntary research subjects (FP) were recruited for the study. The first visit began with obtaining consent to participate in the study. After the consent, a health examination was carried out on fp. If they met all the requirements to be included in the study, they were booked for a visit 2. On visit 2, the microdialysis catheter was placed in the synovial membrane using ultrasound. Fp stayed at the clinic for about 6 hours for microdialysis and safety assessments. Vital parameters were checked during the visit. A follow-up call was made with fp up to 10 days after the trial.