A Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the safety and tolerability of intravaginal
administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1
will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to
14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or
placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug
to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical
inspections will be performed to determine what effect, if any, the study drug has had on the
site of administration. Adverse event data will be collected throughout the trial.