A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig in Adults with Rheumatoid Arthritis or Systemic Lupus Erythematosus

The primary objective is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of surovatamig in adults diagnosed with rheumatoid arthritis or systemic lupus erythematosus. Assessing these parameters is essential to determine the physiological effects and metabolic profile of the investigational product within this patient population.

The study involves a total of 33 patients. The population includes both male and female participants. The cohort is comprised of individuals diagnosed with systemic lupus erythematosus or rheumatoid arthritis. The age range of the subjects is categorized under code 3. The participant group is identified as vulnerable.

This Phase 3 clinical trial is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of surovatamig in adult participants diagnosed with rheumatoid arthritis or systemic lupus erythematosus. The study involves a sequence of scheduled evaluations beginning with a screening visit to assess eligibility. Subsequent follow-up visits and an end-of-study visit are required to monitor clinical parameters and biological responses throughout the duration of the trial. Total participant involvement is determined by the clinical protocols established for the investigation. Early termination from the study may occur based on predefined clinical criteria or safety considerations.

The assessment of efficacy in this Phase 3 clinical trial involves the evaluation of clinical outcomes related to Systemic Lupus Erythematosus and Rheumatoid Arthritis. Specific parameters for determining therapeutic response or disease activity changes are not defined in the current protocol documentation.