Participants
Twenty-four healthy immunocompetent male and female subjects aged
between 18-45 years with Fitzpatrick skin type I-II (Caucasian) and not
smoking more than 10 cigarettes per day were included in the study. The
ratio male:female was 1:1. Subject health status was verified during a
medical screening consisting of a medical history, physical examination,
vital signs, 12-lead electrocardiogram, laboratory analysis of blood and
urine and a Mantoux and/or interferon gamma release assay. Subjects with
a history of tuberculosis were excluded. Routine safety assessments were
performed as described earlier (14). Total observation time was 70 days.