A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis
Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be
enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg.
Three to six patients will be enrolled at each dose level, starting at the lowest dose level,
for a maximum of 24 patients to be enrolled into the study. The study is designed to
establish the safety and tolerability of single doses of MDX-1100 administered in
dose-escalating cohorts to patients with ulcerative colitis. Other study objectives include
characterizing a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and
determination of immunogenic response to MDX-1100.