Clinical Phase I Study of Polyethylene Glycol Treated Human Immunoglobulin (GV-523)

Abstract

1) Three lots of GV-523 (polyethylene glycol treated human immunoglobulin, lyophilized) were tested in administering intravenously to 5 normal volunteers at the dose of 2, 500 mg and to 3 volunteers at the dose of 100 mg/kg body weight. There was no significant adverse reaction during 3 weeks of the observation period.
2) An increase of C-reactive protein was observed in the serum of one volunteer after 11 days of the administration (at the dose of 2, 500 mg), but a direct relationship with GV-523 administration was not evident.
3) Three repeating administration of each 2, 500 mg of GV-523 to 3 volunteers at the intervals of 3 weeks gave no significant adverse reaction and no antigenicity was proved at the passive cutaneous anaphylaxis test in guinea-pig with the use of the volunteer's sera up to 9 weeks.