Evaluation of Safety and Tolerability of Intravenous CPTX2309 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis or Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating CPTX2309, an intravenous drug, to study its safety and tolerability in healthy adults and adults with moderate to severe rheumatoid arthritis RA or systemic lupus erythematosus SLE. This Phase 1, open-label trial investigates both single ascending doses and multiple ascending doses of CPTX2309. The study aims to understand how the drug is tolerated and its potential effects in these populations. The study includes four parts Part A and C involve escalating single doses of CPTX2309 given on specific days, while Part B and D involve escalating multiple doses administered on specified days. These parts are conducted in both healthy adults and adults with moderate to severe RA or SLE. The drug is administered intravenously, and dose escalation allows assessment of safety across increasing doses. Participants will be monitored for up to approximately one year to assess safety parameters including laboratory tests, vital signs, ECGs, antibody development against the drug, and immune responses. Researchers will also measure pharmacokinetic and pharmacodynamic parameters. Study visits will follow a schedule to track these outcomes and ensure participant safety throughout the trial duration.

A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)