The purpose of this study is to determine if SPL7013 Gel (VivaGel™) is safe when applied
topically once a day for seven consecutive days to the shaft and glans of the penis in
healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile
epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the
systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel,
and the acceptability of the study products to the male volunteers.
Phase:
Phase 1
Details
Lead Sponsor:
Starpharma Pty Ltd
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)