Actively Recruiting
A Phase 1 Study to Evaluate Safety and Effects of MK-1045 Given by IV in Adults With Lupus or Rheumatoid Arthritis
Led by Merck Sharp & Dohme LLC · Updated on 2026-07-31
21
Participants Needed
19
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a study medicine called MK-1045 in adults with systemic lupus erythematosus SLE or rheumatoid arthritis RA. The main goal is to learn about the safety and tolerability of MK-1045 when given at different dose levels. This is a phase 1 clinical trial focused on treatment and led by Merck Sharp & Dohme LLC. Participants will receive MK-1045 through intravenous infusion. The study has three parts Part 1 involves single doses at various levels, Part 2 includes three step-up doses over three weeks as prime, step-up, and target doses, and Part 3 offers optional dose expansion with similar dosing. This sequential study uses randomized allocation without masking. During the study, participants will be monitored for adverse events and treatment discontinuations up to approximately 52 weeks depending on the study part. Researchers will also measure how the drug behaves in the body and its effect on peripheral B cell counts. Participants will have regular assessments including safety and pharmacokinetic evaluations throughout the study period, which runs up to July 2029.
CONDITIONS
Brief Title
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Research Team
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