[Clinical studies of SM-4300 in children]

In vitro experiment with phagocytic and bactericidal activity of human neutrophils, SM-4300 augmented opsonic activity against Pseudomonas aeruginosa. After a single dose of 200 mg/kg body weight SM-4300 to a child with common variable immunodeficiency (CVI), serum IgG concentration/time curve was similar to that after PEG-Ig administration. In combination therapies with SM-4300 and antibiotics in 8 children with bacterial infections, beneficial efficacy of SM-4300 was observed. There was no adverse reaction in 16 times injections to 9 children with bacterial infections and 5 times to a child with CVI.