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NCT04731818 · ClinicalTrials.gov registry record · Early Phase 1
An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film
A Early Phase 1 study, sponsored by KBio.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT04731818: Completed Early Phase 1 study, sponsored by KBio.
NCT04731818 is a Early Phase 1 study that has completed, run by KBio. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04731818, a Early Phase 1 study, has completed, sponsored by KBio.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Number of progressively motile sperm in aspirated endocervical mucus when using ZB-06 prior to intercourse.
Interventions
- BIOLOGICAL ZB-06
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-02-08 |
| Est. Completion | 2022-02-24 |
| Phase | Early Phase 1 |
What the finished NCT04731818 record still lists
NCT04731818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which ZB-06 is the first listed.
NCT04731818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04731818 about?
NCT04731818 is a clinical study titled "An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film". 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 saf...
What is the current status of trial NCT04731818?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2021-02-08. Estimated completion is 2022-02-24.
What interventions are being tested in trial NCT04731818?
The interventions under investigation include: ZB-06 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04731818?
This trial is sponsored by KBio, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04731818's enrollment target sits among peer trials
20 1157th of 2000 higher than 709 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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