Is NCT07222020 recruiting in Norfolk, VA?

Yes, NCT07222020 is currently enrolling participants at its Norfolk, VA location. This healthy subjects clinical trial is accepting qualified participants.

How do I join the healthy subjects clinical trial in Norfolk?

To join this clinical trial in Norfolk, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Norfolk clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Healthy Subjects Clinical Trial in Norfolk, VA: KB15A Vaginal Film (Phase 1)

About This Healthy Subjects Study in Norfolk

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.

Sponsor: ZabBio Inc.

Who Can Participate

Inclusion Criteria

Age 18 to 45 years, inclusive

General good health (by volunteer history and per investigator judgment) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes) and with an intact gastrointestinal tract, uterus and cervix.

History of regular menstrual cycles, by volunteer report, if not taking exogenous hormones

History of Pap smears and follow-up consistent with standard clinical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1

Willing to give voluntary consent and sign an informed consent form.

Willing to use non-spermicidal, lubricated condoms for any vaginal intercourse according to the study protocol.

Willing to abstain from intercourse and use of intravaginal medications, lubricants, and other products as required in the protocol.

Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection.

Must be protected from pregnancy by:

Sterilization of either partner

Heterosexual abstinence

Hormonal contraceptives (except for the contraceptive vaginal ring)

If in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive and has no known risk of sexually transmitted infections (STIs)

Exclusion Criteria

History of hysterectomy

Currently pregnant

Currently breastfeeding or planning to breastfeed during the course of the study

Current Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,

Current symptomatic bacterial vaginosis (BV)

Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)

Significant gynecological abnormalities (including abnormal vaginal bleeding, excessive vaginal discharge, or vulvar/vaginal pain or irritation)

Current symptomatic UTI or vaginal candidiasis

History of sensitivity/allergy to KB15A film components, for either the volunteer

Less than 14 days since use of oral or vaginal antibiotics

Women with a history of genital herpes or condylomata who have been symptomatic in the last six months.

Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for an STI

Known current drug or alcohol abuse which could affect study compliance.

Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study

History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days

Abnormal finding on laboratory or physical examination or a social or medical condition in the participant, which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data.

Grade 2 or higher laboratory abnormality, per the 2014 update of the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the Severity of Adverse Events, or clinically significant laboratory abnormality as determined by the clinician.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Norfolk?

Yes, this clinical trial (NCT07222020) has an active research site in Norfolk, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Healthy Subjects Treatment Options in Norfolk, VA

If you're searching for healthy subjects treatment options in Norfolk, VA, this clinical trial (NCT07222020) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Norfolk research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced healthy subjects specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all healthy subjects clinical trials near you to find additional studies recruiting in your area.

Healthy Subjects Clinical Trial in Norfolk, VA

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