At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 20 enrolled
Drug / intervention
ZB-06biological
Likely dose
ZB-06 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory Phase 1 Mechanism-of-action Study of ZB-06, a Vaginal Film Containing HC4-N, an Anti-sperm Monoclonal Antibody.
In Brief
A Early Phase 1 clinical trial evaluating ZB-06 for Contraception. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This is an early Phase 1 study to establish proof-of-concept by determining whether an intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide contraceptive efficacy using the post-coital test, a surrogate measure of efficacy. The study will also evaluate the safety and pharmacokinetics of ZB-06.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
CollaboratorsEastern Virginia Medical School
Timeline
Early Ph 1CompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartFeb 2021
Primary CompletionJan 2022
Study CompletionFeb 2022
TodayJul 2026
First PostedFeb 1, 2021
Enrollment StartFeb 8, 2021
Primary CompletionJan 25, 2022
Study CompletionFeb 24, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.4 years ago
Interventions
ZB-06biological
ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.