A First-in-Human Study to Assess the Safety of a New Investigational Medicine (MQ005) in Adults with Sepsis

MQ005 is a recombinant, fully human IgM monoclonal antibody targeting straight chain poly-N-acetyllactosamine (scPNAL) on specific immune cells. It is administered intravenously over approximately 30 minutes using an infusion pump with a 0.2 µm inline filter, followed by a 10 mL normal saline flush. Doses are weight-based by cohort (0.2, 0.5, 1.0, 2.0, or 4.0 mg/kg), with a capped maximum dose of 400 mg for subjects weighing more than 100 kg. The study uses a sentinel and cohort-based dose escalation design. Each cohort begins with a sentinel subject who receives a single dose. Subsequent subjects in that cohort may begin dosing only after a 72-hour safety review of the sentinel subject has been completed and no safety signals are identified in the opinion of the investigator. Subsequent subjects may receive once-daily dosing for up to five total daily doses, provided there are no new immunologic adverse events and the subject’s clinical status has not worsened. MQ005 is administered by trained clinical staff at the study site. Adherence is ensured through direct administration and observation, with infusion start and stop times, dosing windows (±1 hour), and dose completion recorded in source documentation and case report forms. Drug preparation and accountability are managed according to the Pharmacy Manual. No other investigational or immunomodulatory agents are permitted during the study, except standard-of-care treatments for sepsis (including corticosteroids when clinically indicated). Safety monitoring includes clinical assessments, laboratory testing, electrocardiograms, and adverse event reporting through Day 28.