First in Human Clinical Trial of a Contraceptive MPT YASO GEL

Yaso Therapeutics Inc, Phoenix AZ

Investigators

Abstract

PROJECT SUMMARY Polyphenylene carboxymethylene sodium salt (PPCM) is being developed by Yaso Therapeutics as a woman- controlled, on-demand vaginal gel (YASO-GEL) that is both contraceptive and microbicidal. We have advanced PPCM and YASO-GEL through preclinical evaluation, successfully submitted our IND, and are ready for clinical evaluation. In this application, we propose to conduct a Phase 1 First-in-Human clinical trial to evaluate the safety and pharmacokinetics of genital use of YASO-GEL in women and men. In addition to standard safety testing and pharmacokinetics, we will conduct assays to assess the impact of YASO-GEL on the vaginal microbiome and immune factors. We will also gather preliminary data on the efficacy of YASO-GEL in the vagina by evaluating the sperm in post-coital samples for motility, viability, and acrosome loss. Microbicidal activity against both Neisseria gonorrhoeae and HIV will also be assessed in ex vivo samples.