drugset / Trial / NCT05368857

DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers

NCT05368857 ↗

Phase 1 Completed 10 enrolled Clinuvel (UK) Ltd.
NaSingle-groupOpen-labelPrevention

Summary

This mechanistic study's aim is to assess the DNA damage repair capabilities of afamelanotide in healthy volunteers with skin type I-III following exposure to ultraviolet radiation (UVR)-induced DNA damage.

Timeline

Start
2022-01-19
Primary completion
2023-02-01
Completion
2023-02-01

Outcome

Met primary endpoint

release “Afamelanotide in study CUV151, skin biopsy results: 1. reduces cyclobutane pyrimidine dimers (CPDs) in ultraviolet (UV) irradiated skin (n=9)” clinuvel.com ↗

release “Following afamelanotide, the percentage of cells presenting CPDs was reduced significantly at 15 minutes, 24 hours , and 48 hours following UV irradiation (p<0.01).” clinuvel.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Afamelanotide Peptide — Subcutaneous

Indications

No indication recorded.