Study on the Effects of Afamelanotide on UV Radiation-Induced DNA Damage and Repair in Healthy Volunteers

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called afamelanotide, which is a synthetic hormone analogue, on the skin of healthy individuals. The study aims to understand how this treatment impacts DNA damage caused by ultraviolet radiation (UVR) and the skin’s ability to repair this damage. The treatment is administered as a solution for injection under the skin, known as a subcutaneous injection.

The purpose of the study is to evaluate how afamelanotide affects the skin’s response to UVR, specifically looking at changes in DNA damage before and after the treatment. Participants in the study are healthy volunteers, meaning they do not have any underlying health conditions that could affect the study’s results. The study will involve monitoring the skin’s reaction to UVR exposure and assessing any changes in DNA damage and repair capacity.

Throughout the study, participants will receive the treatment and undergo assessments to measure the impact on their skin. The study is designed to provide insights into how afamelanotide can potentially protect the skin from UVR-induced damage, which could have implications for future treatments or preventive measures. Participants will be closely monitored to ensure their safety and well-being during the study period.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You will be assessed to ensure you meet the eligibility criteria, which include being a healthy adult aged 18 to 45, having a body mass index (BMI) between 18 and 30, and having normal heart rate, blood pressure, and organ function.

2 initial assessment

An initial assessment will be conducted to confirm your health status. This includes a review of your medical history, laboratory tests, and vital signs.

You will be asked to refrain from using any non-prescribed medications and to take precautions to prevent pregnancy during the study.

3 administration of medication

You will receive an injection of afamelanotide, which is a solution administered under the skin (subcutaneous injection).

The purpose of this medication is to evaluate its impact on DNA damage and repair in your skin when exposed to ultraviolet radiation (UVR).

4 monitoring and evaluation

Your skin will be monitored for changes in response to UVR exposure, both before and after receiving afamelanotide.

The study aims to assess the changes in UV-induced DNA damage in your skin.

5 completion of study

The study is expected to conclude by December 6, 2024. Your participation will help in understanding the effects of afamelanotide on skin DNA damage and repair.

Who Can Join the Study?

Must be a healthy adult male or female.
Age must be between 18 and 45 years old.
Heart rate should be between 50 and 90 beats per minute (bpm).
Blood pressure should be below 120/80 mm Hg and above 90/60 mm Hg.
Must have normal kidney and liver function, as shown by lab tests.
Must be willing and able to follow the study rules and procedures.
Should not have any significant abnormal findings during the screening process, which includes medical history, lab tests, and checking vital signs.
Body Mass Index (BMI) should be between 18 and 30 kg/m². BMI is a measure of body fat based on height and weight.
No history of drug abuse, whether legal or illegal, as checked through medical history and a urine drug test.
Must agree not to use any medications that are not prescribed by a doctor.
Must be willing to take steps to prevent pregnancy with their partner.
Must be able to understand and sign a written Informed Consent form before any study-specific procedures are done. This means they agree to participate in the study after being informed about it.

Who Cannot Join the Study?

Participants must be healthy volunteers. This means you should not have any ongoing medical conditions.
Participants must be within a specific age range, which is typically defined by the study.
Both male and female participants are eligible, but you should not be part of a vulnerable population. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	13.05.2024

Trial locations

Investigated drugs:

Afamelanotide

Afamelanotide is a medication being studied for its potential to protect the skin from damage caused by ultraviolet (UV) radiation. In this trial, it is used in a liquid form to see how well it can prevent or repair damage to the DNA in skin cells after exposure to UV light. The goal is to understand if afamelanotide can help the skin heal itself better after being in the sun, which might reduce the risk of skin problems caused by UV rays.

Healthy volunteers – This term refers to individuals who do not have any known medical conditions or diseases. They are typically used in clinical trials to establish baseline data or to test the effects of new treatments or interventions. Healthy volunteers are characterized by their normal physiological functions and absence of significant health issues. They help researchers understand how a treatment affects a typical human body without the interference of disease-related factors. The progression of their health status is generally stable, as they do not have underlying conditions that alter their health over time.

Trial ID:

2023-505907-21-00

Protocol code:

CUV158

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Afamelanotide on UV Radiation-Induced DNA Damage and Repair in Healthy Volunteers

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