Trials / Completed
CompletedNCT04731818
An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film
An Exploratory Phase 1 Mechanism-of-action Study of ZB-06, a Vaginal Film Containing HC4-N, an Anti-sperm Monoclonal Antibody.
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- KBio Inc · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ZB-06 | ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration. |
Timeline
- Start date
- 2021-02-08
- Primary completion
- 2022-01-25
- Completion
- 2022-02-24
- First posted
- 2021-02-01
- Last updated
- 2025-01-15
- Results posted
- 2025-01-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04731818. Inclusion in this directory is not an endorsement.