Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris
Status:
Completed
Trial end date:
2012-12-31
Target enrollment:
Participant gender:
Summary
This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in
subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via
subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of
3 injections. Study drug will be administered under close observation in a facility equipped
to handle medical emergencies. Subjects will not be discharged from the facility until at
least 1 hour following the injection or 1 hour after their vital signs have stabilized.
Safety will be assessed by pre- and post-treatment serial measurements of vital signs,
clinical laboratory assessments, and the recording of adverse clinical events.
Phase:
Phase 2
Details
Lead Sponsor:
Janssen Research & Development, LLC XBiotech, Inc.