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

Clinuvel

Status and phase: Completed; Phase 1

Conditions: Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

Treatments: Drug: Afamelanotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05368857

CUV151

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Afamelanotide

Experimental group

Treatment:

Drug: Afamelanotide