Development of an ultrapotent anti-sperm antibody construct for non-hormonal contraception

We will perform studies in sheep for assessment of pharmacokinetics, safety, and surrogate efficacy of the API delivered vaginally. Studies will include use of the IVRs, collection of fluid and tissue samples and genital tract images. Pharmacokinetic assessments will include collection of fluid and tissues (eg vaginal secretions and tissues). Safety assessments will include colposcopy imaging and biopsies to evaluate for mucosal disruption and inflammation. Surrogate efficacy will be assessed using post-coital testing (PCT) in sheep using fresh human sperm collected under an IRB protocol allowing for collection of fresh semen samples from male volunteers.