Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Efficacy, safety, and dose-response of a Live Biotherapeutic Product (BGY-1601-VT, vaginal tablet) as a first-line monotherapy in women with acute vaginal infection: a randomized, double-blind, placebo-controlled study

This research is looking into a new type of treatment, a vaginal tablet called BGY-1601-VT, for women who have a common vaginal infection. The goal is to understand if this new tablet is effective at clearing up the infection, how safe it is to use, and what the best amount (dose) of the tablet should be. We are doing this by comparing the new tablet to a 'dummy' tablet that looks the same but contains no active medicine. This helps us see if any improvements are genuinely due to the new treatment or other factors. This is an early stage of testing in humans, combining the first steps to see if it's safe with steps to find the right dose. Participants will be women aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Nexbiome Therapeutics

Enrolment target

165

Start

21 Jun 2024

Gynaecological

What is this study about?

This study is about finding a new way to treat common vaginal infections that many women experience. We are testing a special new vaginal tablet called BGY-1601-VT. This tablet contains what's known as a 'live biotherapeutic product', which means it uses beneficial microbes to help restore natural balance in the vagina.

The main goal of this research is to see if this new tablet can successfully clear up the infection. We also want to understand how safe it is for women to use and to work out the best dose. To do this fairly, some women will receive the new tablet, and others will receive a 'dummy' tablet (a placebo) that looks identical but has no active ingredients. This helps researchers truly understand if the new treatment is making a difference.

This is a combined Phase I and Phase II study, which means it's one of the first times this treatment is being given to people. In these early stages, researchers are carefully checking for any side effects and trying to find the most effective and safest dose for patients. Your participation could help develop better treatments for vaginal infections in the future.

Key takeaways

This study is testing a new vaginal tablet for common vaginal infections.
It aims to find out if the new tablet is safe, effective, and what dose works best.
Some participants will receive the new tablet, others a dummy tablet (placebo).
It's an early-stage study, meaning it's one of the first times it's used in people.
If you have a vaginal infection and are 18 or older, you might be eligible.

Who may be eligible?

To be able to take part in this study, you need to be a woman who is at least 18 years old. There is no upper age limit for joining.

Beyond your age and sex, the researchers will also be looking for women who currently have an acute (meaning it's come on recently) vaginal infection. They will check this with specific medical tests and assessments to make sure you fit the study criteria.

There will also be other medical checks and questions to ensure the study is safe for you and that you meet all the necessary requirements. This is to protect your health and make sure the study results are clear and accurate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female?
Are you 18 years old or older?
Do you currently have an acute (recent onset) vaginal infection?
Are you able to attend clinic visits as required by the study?
Are you willing to potentially receive a dummy tablet (placebo)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new vaginal tablet (BGY-1601-VT) or a dummy tablet. You'll use these as instructed. The study involves several visits where doctors and nurses will check your progress and overall health. They will look at your symptoms and conduct examinations. You might also be asked to keep a diary of your symptoms and how you feel. Doctors will assess if your symptoms improve and if you need any other 'rescue' treatments. They will also collect samples, like vaginal secretions, to understand how the treatment affects the natural balance of bacteria. They will also keep a close eye on any side effects you might experience. The total duration of your involvement, including all visits and follow-ups, will be explained in detail before you agree to participate.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from receiving a new and potentially effective treatment for your vaginal infection before it's widely available. However, there's also a chance you might receive the dummy tablet, or that the new treatment may not work for you. There could be side effects from the medication you receive, even if it's the dummy tablet. All possible common and serious side effects will be fully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Germany

Common questions

What is a 'live biotherapeutic product'?

It's a type of medicine that uses beneficial living microorganisms, like good bacteria, to help improve your health, in this case, to help rebalance the vaginal environment.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the new treatment fairly.

Why is it 'double-blind'?

Double-blind means neither you nor your study doctor will know if you are receiving the new tablet or the placebo. This helps prevent bias and ensures results are fair.

What does 'first-line monotherapy' mean?

It means this new tablet is being tested as the first and only treatment given for the infection, rather than being used alongside other medicines.

What is 'clinical cure'?

Clinical cure means your symptoms have gone away, and medical examinations show that the infection has cleared up, without needing other treatments.