A Mechanistic Study to Evaluate Impact of Afamelanotide in Aqueous Solution on Ultraviolet Radiation-Induced DNA Damage and DNA Repair Capacity in Healthy Volunteers

Phase 1

Conditions: Healthy volunteers
Therapeutic area: Not possible to specify

Registration Number: CTIS2023-505907-21-00

Lead Sponsor: Clinuvel Europe Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Healthy adult males and females aged between 18 and 45 years (inclusive) (heart rate between 50 and 90 bpm, blood pressure below 120/80 mm Hg and above 90/60 mm Hg and normal renal and hepatic function as determined through laboratory testing), Willing and able to comply with the conditions specified in the protocol and study procedures, in the opinion of the Investigator., Free of significant abnormal findings as determined during the screening procedure by medical history, laboratory testing and vital signs., Body Mass Index (BMI) between 18 and 30 kg/m2., No history of drug abuse, licit or illicit assessed through medical history review and a urine drug screening test, Agree not to use any non-prescribed medications., Willing to take precautions to prevent pregnancy with their partner., Able and willing to follow the protocol requirements., Able to understand and provide written Informed Consent prior to the performance of any study-specific procedure.

Exclusion Criteria

Any personal or family history of melanoma or personal history of dysplastic nevus syndrome., 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., Taking medications that are known photosensitisers., Individual history of basal cell carcinoma, squamous cell carcinoma (inclusive carcinoma in situ e.g. Bowen’s disease), Merkel cell carcinoma or other malignant or premalignant skin lesions., Regularly drinks more than four units of alcohol per day., Participation in any clinical study during the six weeks before Screening., Any significant illness prior to the study screening period., Solarium use/sunbathing prior to study involvement and throughout the duration of the study., Not suitable for study participation in the opinion of the Investigator., Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator’s Brochure., Any medical condition which may interfere with the study protocol., Female who is pregnant or lactating.