On-demand antibody vaginal film for contraception
Project 2: Phase 1 and Phase 2a ZB-06 Clinical Studies
Trying a single-use, non-hormonal vaginal film that releases an antibody to prevent pregnancy for people who want on-demand birth control.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Boston University Medical Campus NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-11168798 on NIH RePORTER |
What this research studies
You would use a thin, non-hormonal vaginal film that dissolves and releases a human contraceptive antibody shortly before sex. The team is running Phase 1 and Phase 2a trials including placebo-controlled, double-blinded, randomized safety and pharmacokinetic studies with single and multiple doses. They will perform post-coital testing to measure progressively motile sperm in cervical mucus after intercourse and collect safety and drug-level samples. Visits take place at U.S. clinic sites and include product insertion, follow-up safety checks, and specimen collection.
Who could benefit from this research
Good fit: People with a uterus seeking short-term, non-hormonal contraception who can attend clinic visits at U.S. sites are the ideal candidates.
Not a fit: Those who prefer continuous long-term contraception, cannot use vaginal products, or cannot travel to in-person clinic visits are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this could provide a hormone-free, user-controlled, on-demand contraceptive option.
How similar studies have performed: Early first-in-human data (ClinicalTrials.gov NCT04731818) showed the 20 mg film was safe, acceptable, and greatly reduced progressively motile sperm in cervical mucus, but larger trials are still required.
Where this research is happening
Boston, United States
- Boston University Medical Campus — Boston, United States (Active)
Researchers
- Principal investigator: Thurman, Andrea Ries — Boston University Medical Campus
- Study coordinator: Thurman, Andrea Ries
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.