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

• Status: Recruiting
• Trial end date: 2022-05-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Clinuvel (UK) Ltd.
• Treatments: Afamelanotide

Criteria

Inclusion Criteria:

• Healthy male or female volunteers (aged 18-45) with Fitzpatrick skin types I, II or III.

• Written informed consent obtained from volunteers prior to study-start.

Exclusion Criteria:

• Female who is pregnant or lactating.

• Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.

• Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.

• Any significant illness during the four weeks before the study screening period.

• Taking known photosensitisers.