Eastern Virginia Medical School (EVMS)

Team Members:

Andrea Thurman, M.D. serves as Project Lead on Project 2. She led the first CRC clinical trial (ZB-06-01) while serving as Professor of Obstetrics and Gynecology and Director of the Clinical Research Center, CONRAD, Eastern Virginia Medical School (Norfolk VA) and has over 18 years of experience conducting translational clinical and laboratory studies of contraceptive products, including use of the postcoital test. She presently serves as Medical Director at Daré Bioscience.

David Archer, M.D. will conduct the Phase 1 safety/PK trial and the Phase 2a dose finding post coital test trial. Dr. Archer is Professor of Obstetrics and Gynecology and Director of the Clinical Research Center, CONRAD, Eastern Virginia Medical School (Norfolk VA).

Specific Aims for Project 2:

Project 2 will develop, conduct and supervise two required and critical clinical studies in the development pipeline, which build upon current data and will ready the HCA film for pivotal Phase 2b/3 efficacy trials.

1. Develop the clinical protocols, regulatory documents, operations manuals and perform site training to assure that quality data are collected under good clinical practices (GCP) with minimal risks to human subjects.

2. Perform a Phase 1 Placebo-Controlled, Double-Blinded, Randomized, Safety and Pharmacokinetic Study of Single and Multiple Dosing of ZB-06, a vaginal film containing HCA, an Antisperm Monoclonal Antibody (Study 1).

3. Perform a Phase 2a multi-center (EVMS and UT Health), interventional, cross-over, single-blinded, PK, dose finding study of the ZB-06 vaginal film at three doses of HCA: 5 mg, 10 mg and 20 mg (Study 2).