KB15A Vaginal Film for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is evaluating a new vaginal film called KB15A, which contains an antibody designed to prevent sperm from functioning. The main goal is to assess its safety and how it behaves in the body compared to a placebo (a treatment with no active ingredients). Researchers seek healthy women aged 18 to 45 with regular menstrual cycles who are willing to use condoms during the study. Participants should not have major health issues or be pregnant, and they should be in a committed relationship with a partner free from STIs (sexually transmitted infections). As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not have used oral or vaginal antibiotics in the last 14 days before joining the study.
Is there any evidence suggesting that KB15A is likely to be safe for humans?
Previous studies have shown that KB15A, a vaginal film with an anti-sperm antibody, is safe and well-tolerated. Research indicates that users found the film acceptable, with no major side effects reported. Additionally, the study found no long-term increases in certain proteins that could indicate inflammation after using the film. This suggests that KB15A is generally safe for human use.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about KB15A because it's a vaginal film, which is a new and convenient delivery method compared to current options like oral medications or creams. This film dissolves directly at the site of action, potentially offering faster and more targeted relief. Unlike other treatments that might have systemic side effects, KB15A's localized application could minimize those risks, making it a promising advancement in women's health.
What evidence suggests that KB15A might be an effective treatment for contraception?
Research shows that KB15A, a vaginal film with an anti-sperm antibody, maintains effective antibody levels in the vagina for at least 3 hours after use. This suggests the film might temporarily block sperm after application. In this trial, participants will receive either the KB15A film or a placebo film. Studies on similar films, such as MB66, have found them to be safe and well-tolerated by users. Although exact data on pregnancy prevention is not yet available, the method of antibody delivery appears promising. Ongoing research aims to confirm these early results and ensure the product's safety for users.13467
Are You a Good Fit for This Trial?
This trial is for healthy adult women aged 18-45 who are willing to use condoms and abstain from other vaginal products during the study. They should have no significant systemic diseases, regular menstrual cycles (if not on hormones), and be able to provide informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single-Dose Phase
Participants receive two single doses of either KB15A or placebo vaginal film, separated by approximately 1 week
Washout Period
A washout period between the single-dose and multiple-dose phases
Multiple-Dose Phase
Participants receive 14 consecutive daily doses of either KB15A or placebo vaginal film
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KB15A
Trial Overview
The trial is testing KB15A, a vaginal film with an anti-sperm antibody, against a placebo. It aims to assess safety and how the body absorbs and distributes KB15A after single or multiple uses.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
KB15A (Vaginal Film)
Placebo (Vaginal Film)
Find a Clinic Near You
Who Is Running the Clinical Trial?
ZabBio Inc.
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Boston University
Collaborator
Old Dominion University
Collaborator
Citations
NCT07222020 | Phase 1 Study of Intravaginal KB15A
The goal of this clinical trial is to determine the safety and mucosal pharmacokinetics of KB15A, a vaginal film containing an anti-sperm ...
KB15A Vaginal Film Safety in Healthy Women
This study focuses on a new contraceptive method for women aged 18 to 45, using a vaginal film called KB15A. This film contains a special protein that targets
KB15A Vaginal MPT Film
Phase 1 clinical trial concludes that an MB66-based film is safe, well-tolerated and acceptable to users. Study does not include contraceptive efficacy ...
Project 1: Industrialization of ZB-06
The Phase 1 clinical trial of MB66 showed that it was safe and well tolerated, and that vaginal samples collected up to 24 hours after MB66 insertion ...
ZB-06, a vaginal film containing an engineered human ...
The PK and surrogate PD data support that the film provides effective levels of mucosal anti-sperm antibodies for at least 3 hours post use.
KB-15A - Drug Targets, Indications, Patents
... Safety and Pharmacokinetic Study of Single and Multiple Dosing of KB15A, a Vaginal Film Containing KB15A, an Anti-Sperm Monoclonal Antibody. 100 Clinical ...
86604-86-6_C13013_en.pdf - 普西唐试剂官网
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