Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Not yet recruiting
Study on the Effects of Afamelanotide on UV Radiation-Induced DNA Damage and Repair in Healthy Volunteers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- 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 trial?
3 criteria
- 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.
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Investigated drugs
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.
What is already known about the treatment
Afamelanotide – Afamelanotide is administered in an aqueous solution, typically applied to the skin. It is currently being studied in clinical trials to understand its effects on DNA damage and repair in healthy volunteers exposed to ultraviolet (UV) radiation. The main therapeutic indication being explored is its potential to protect skin from UV-induced damage. At the molecular level, afamelanotide works by stimulating the production of melanin, the pigment that gives skin its color, which can help absorb UV radiation and reduce DNA damage. It is classified pharmacologically as a melanocortin receptor agonist.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505907-21-00Protocol codeCUV158Estimated enrolment10 patientsSponsorClinuvel Europe Limited
sourced from the EU Clinical Trials Register and site verification
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