Phase 1ab Study to Assess Safety and Tolerability of NTR-1011 in Healthy Adults and Adults With Systemic Lupus Erythematosus or Rheumatoid Arthritis

What this Trial Is About

Researchers are studying the safety and tolerability of NTR-1011, a fusion protein designed to reduce inflammation by clearing neutrophil extracellular traps, in adults with systemic lupus erythematosus SLE and rheumatoid arthritis RA, as well as in healthy adult volunteers. This Phase 1ab clinical trial aims to determine the highest safe dose of NTR-1011 given either under the skin or intravenously, understand how the body processes the drug, assess immune response to it, and explore early signs of benefit when added to standard treatments. The study has two parts Phase 1a, completed with healthy volunteers receiving single doses of NTR-1011 or placebo via intravenous or subcutaneous routes and Phase 1b, currently recruiting adults with moderate-to-severe SLE or RA who receive five weekly intravenous doses of NTR-1011 alongside their usual care. Dose levels in Phase 1b are adjusted based on safety and response data. No placebo group exists in Phase 1b, and participants are assigned to either the SLE or RA group. Participants undergo physical exams, lab tests, vital sign monitoring, and blood sampling to measure drug levels, immune markers, and antibodies against NTR-1011. Clinical assessments include disease activity scores and patient-reported outcomes specific to SLE and RA. Safety and tolerability are closely monitored throughout treatment and for four weeks after the last dose. The studys findings will help guide future development and dosing of NTR-1011 for autoimmune diseases.

Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA