Project 3: Film Formulation, PK/PD and Safety Studies of ZB-06

Summary

This project aims to optimize vaginal film delivery systems for the Human Contraception Antibody (HCA), develop immediate and extended-release formulations, and conduct PK/PD and safety studies using vaginal samples from women in clinical trials.

What they want

The primary objectives are to optimize the vaginal film delivery system for HCA and perform assays to assess PK/PD and safety endpoints in vaginal samples from women in clinical trials. Vaginal film optimization will include developing an immediate-release film for clinical trials and an extended-release film for >3 days of contraceptive antibody delivery. Dr. Rohan will oversee the transfer of immediate-release film production to KBio. Antibody studies (concentration and activity) for film optimization and clinical PK/PD trials will be conducted in Dr. Anderson’s laboratory. Dr. Anderson’s laboratory will also evaluate safety endpoints in women enrolled in clinical trials, including vaginal inflammation, changes in the vaginal microbiome and gene expression pathways, and de novo development of antisperm immunity.

Deliverables

Improved vaginal film formulations for immediate HCA release
Improved vaginal film formulations for extended HCA release (>3 days)
Data from exploratory PK/PD endpoint evaluations (HCA concentrations and activity)
Data from exploratory safety endpoint assessments (vaginal inflammation, microbiome changes, gene expression, antisperm immunity)

Technical requirements

Optimization of vaginal film delivery systems for Human Contraception Antibody (HCA)
Development of immediate-release film formulations
Development of extended-release film formulations (>3 days release)
Assays to measure HCA concentrations and activity in vaginal samples
Assessment of vaginal inflammation
Analysis of changes in the vaginal microbiome
Evaluation of gene expression pathways
Assessment of de novo development of antisperm immunity