Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT07222020
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Intravaginal KB15A
Sponsor:
ZabBio Inc.
Organization:
Study Overview
Official Title:
Phase I, Placebo-Controlled, Double-Blinded, Randomized, Interventional, Safety and Pharmacokinetic Study of Single and Multiple Dosing of KB15A, a Vaginal Film Containing KB15A, an Anti-Sperm Monoclonal Antibody
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the safety and mucosal pharmacokinetics of KB15A, a vaginal film containing an anti-sperm monoclonal antibody, in healthy adult women. Researchers will compare KB15A use to placebo use, primarily to see if KB15A is associated with adverse events, and also to understand the local and systemic distribution of the KB15A monoclonal antibody following use of the vaginal film.
Participants will be assessed for the genital, mucosal and systemic safety and pharmacokinetics of KB15A in a preliminary single-dose phase of the study, where they will receive two single doses of either KB15A or placebo vaginal film, and again in a multiple-dose phase of the study, where they will receive 14 daily doses of either KB15A or placebo vaginal film.
Participants will be assessed for the genital, mucosal and systemic safety and pharmacokinetics of KB15A in a preliminary single-dose phase of the study, where they will receive two single doses of either KB15A or placebo vaginal film, and again in a multiple-dose phase of the study, where they will receive 14 daily doses of either KB15A or placebo vaginal film.
Detailed Description:
KB15A is a polyvinyl-alcohol (PVA) based intravaginal contraceptive film Drug Product manufactured by KBio, Inc. containing the KB15A.16.2 Drug Substance. KB15A.16.2 is an IgG1 monoclonal antibody that targets CD52g, a unique glycan present on the surface of human sperm. KB15A is thought to work as a contraceptive by binding and trapping sperm in the vagina, so that they cannot migrate past the cervix and fertilize an oocyte.
This study will determine whether the KB15A film is safe in healthy women 18 - 45 years of age; it will also determine where the KB15A antibody is distributed in the body after film use. Participants must not be at risk of pregnancy due to one of the following approved methods of contraception or abstinence:
* prior surgical sterilization of self or sexual partner
* oral contraceptive pills
* transdermal patch
* contraceptive injection
* hormonal intrauterine system (IUS)
* heterosexual abstinence, or
* copper intrauterine device
Participants will be assessed for the genital, mucosal and systemic safety and pharmacokinetics of KB15A in two sequential study phases, separated by an approximately 2 - 6 week wash out period:
1. A preliminary single-dose phase of the study where participants will receive two single doses of either KB15A or placebo vaginal film, separated by approximately 1 week;
2. A multiple-dose phase of the study where participants will receive 14 consecutive daily doses of either KB15A or placebo vaginal film.
For the primary objective of the study, participants will be evaluated for Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures, changes in colposcopic findings, and changes in systemic laboratories (e.g. complete blood count, chemistry panel) after two single doses in the single dose phase, and again after 14 daily doses in the multiple dose phase.
The secondary objective of the study is to describe the concentration of monoclonal antibody locally in the cervicovaginal mucosa, and systemically in the blood. Pharmacokinetics will be measured at baseline and at 30 minutes and 1, 2, and 4 hours after the first single dose; at 30 minutes and 8 or 48 hours after the second single dose (depending on the pharmacokinetic sampling time point randomization assignment); at 1, 4, 8, and 24 hours after the 1st dose of film in the multiple dose phase; and 24 hours after the 14th dose in the multiple dose phase. Finally, pharmacokinetics will be measured 5 - 8 days after the 14th dose of the film in the multiple-dose phase.
This study will determine whether the KB15A film is safe in healthy women 18 - 45 years of age; it will also determine where the KB15A antibody is distributed in the body after film use. Participants must not be at risk of pregnancy due to one of the following approved methods of contraception or abstinence:
* prior surgical sterilization of self or sexual partner
* oral contraceptive pills
* transdermal patch
* contraceptive injection
* hormonal intrauterine system (IUS)
* heterosexual abstinence, or
* copper intrauterine device
Participants will be assessed for the genital, mucosal and systemic safety and pharmacokinetics of KB15A in two sequential study phases, separated by an approximately 2 - 6 week wash out period:
1. A preliminary single-dose phase of the study where participants will receive two single doses of either KB15A or placebo vaginal film, separated by approximately 1 week;
2. A multiple-dose phase of the study where participants will receive 14 consecutive daily doses of either KB15A or placebo vaginal film.
For the primary objective of the study, participants will be evaluated for Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures, changes in colposcopic findings, and changes in systemic laboratories (e.g. complete blood count, chemistry panel) after two single doses in the single dose phase, and again after 14 daily doses in the multiple dose phase.
The secondary objective of the study is to describe the concentration of monoclonal antibody locally in the cervicovaginal mucosa, and systemically in the blood. Pharmacokinetics will be measured at baseline and at 30 minutes and 1, 2, and 4 hours after the first single dose; at 30 minutes and 8 or 48 hours after the second single dose (depending on the pharmacokinetic sampling time point randomization assignment); at 1, 4, 8, and 24 hours after the 1st dose of film in the multiple dose phase; and 24 hours after the 14th dose in the multiple dose phase. Finally, pharmacokinetics will be measured 5 - 8 days after the 14th dose of the film in the multiple-dose phase.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P50HD096957-08 | NIH | None | https://reporter.nih.gov/quic… | View |