Status:
COMPLETED
DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
Lead Sponsor:
Clinuvel (UK) Ltd.
Conditions:
Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05368857
Start Date
January 19 2022
End Date
February 1 2023
Last Update
February 9 2023
Active Locations (1)
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1
CLINUVEL Investigational Site
Clinuvel Investigational Site, United Kingdom