Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED PHASE I TRIAL TO INVESTIGATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE ASCENDING TOPICAL DOSES OF GZ21T IN HEALTHY VOLUNTEERS

This is a very early study, called a Phase I trial, looking at a new skin cream called GZ21T. Doctors want to understand if this cream is safe to use on people and how well the body handles it. They are specifically interested in how much of the medicine gets absorbed when different amounts are applied to the skin. The study is for healthy adults, and it's designed to gather basic information as a first step before testing it in patients with sun-damaged skin, known as actinic keratosis. Participants will get either the new cream or a dummy cream (placebo) without knowing which one they have. This helps ensure the results are accurate and reliable.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Ankh Life Sciences Limited

Enrolment target

Start

12 Jul 2024

Actinic keratosis

What is this study about?

This study is a very early step in testing a new cream called GZ21T. Think of it like a first road-test for a new car – we're not seeing if it's better than other cars yet, but if it runs safely and how much fuel it uses. In this case, researchers want to see if the new cream is safe for people to use on their skin, how well their bodies handle it, and how much of the medicine gets into the body when different doses are applied. This type of study is called a "Phase I" trial, and it's carried out in healthy volunteers before it's tested in people who actually have the condition.

The cream is being developed for a skin condition called actinic keratosis. This condition involves rough, scaly patches on the skin that develop after years of sun exposure. While this study isn't directly treating actinic keratosis yet, the information gathered here about safety and how the body handles the cream is essential before it can be studied in people with the condition later on.

By taking part, you would be helping medical science develop new potential treatments. The results from this study will help doctors decide if and how to move forward with further research using GZ21T. Your contribution, as a healthy volunteer, is crucial for understanding how this new treatment works in the human body.

Key takeaways

This is an early study (Phase I) of a new skin cream called GZ21T.
It aims to check the cream's safety, how the body handles it, and how much is absorbed.
The study involves healthy volunteers, not people with actinic keratosis (sun-damaged skin) yet.
Participants will receive either the new cream or a dummy cream, and nobody will know which one until the study ends.
Your involvement helps pave the way for potential future treatments for actinic keratosis.

Who may be eligible?

To join this study, you need to be a healthy adult, aged 18 or older. Both men and women can take part. Since this is an early safety study, it's focused on people who are generally well, rather than those with specific illnesses.

There might be other health conditions or medications that would prevent you from joining, but these will be checked carefully by the study team. For example, if you have certain medical conditions or are taking particular medicines, you might not be able to participate for your safety and to make sure the study results are clear.

The main idea is that the study needs people who are in good health so that any effects seen can be clearly linked to the new cream being tested, rather than other health issues.

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 18 years old or older?
Are you generally in good health?
Are you comfortable with regular health checks and blood tests?
Are you able to attend clinic appointments as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new cream (GZ21T) or a dummy cream (a placebo) to use on your skin, but neither you nor the study doctors will know which one you have – this is called "double-blind." You will apply a single dose of the cream. You will have several visits to the clinic where doctors and nurses will check your health. This will involve regular examinations, blood tests to see how much of the medicine is in your body, and questions about how you are feeling. The exact number of visits and the total duration of your participation will be explained in detail by the study team, but typically, these early-stage studies involve a few clinic visits over a relatively short period, followed by some follow-up checks.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research and helping develop new treatments for skin conditions. However, since this is a very early study and you are a healthy volunteer, there's no direct personal health benefit expected. Potential risks might include side effects from the cream, such as skin irritation where it's applied, or discomfort from blood tests. The study team will carefully monitor you for any problems. Remember, taking part is voluntary, and you can stop at any time for any reason without it affecting your medical care.

Locations (1)

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

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Unverified
Sweden

Common questions

What is actinic keratosis?

Actinic keratosis is a common skin condition caused by too much sun exposure. It typically appears as rough, scaly patches on the skin.

What does 'single ascending topical doses' mean?

It means the study will test different amounts (doses) of the cream applied to the skin, starting with a small amount and gradually increasing it in different groups of people, to find a safe and effective range.

What is a 'double-blind, placebo-controlled' study?

Double-blind means neither you nor the doctors know if you're getting the active cream or a dummy cream (placebo). Placebo-controlled means some participants receive a dummy cream, which helps compare the new cream's effects accurately.

Will I get the actual treatment?

You will either receive the new cream (GZ21T) or a dummy cream (placebo). You won't know which one you're getting until after the study is over, if the researchers decide to tell participants.

How long will I need to be involved in the study?

The information above doesn't specify an exact duration, but typically Phase I studies involve a few clinic visits and follow-up over a period generally lasting weeks, not months or years. The study team will provide precise details.