AFAMELANOTIDE for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- 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)\n- Willing and able to comply with the conditions specified in the protocol and study procedures, in the opinion of the Investigator.\n- Free of significant abnormal findings as determined during the screening procedure by medical history, laboratory testing and vital signs.\n- Body Mass Index (BMI) between 18 and 30 kg/m2.\n- No history of drug abuse, licit or illicit assessed through medical history review and a urine drug screening test\n- Agree not to use any non-prescribed medications.\n- Willing to take precautions to prevent pregnancy with their partner.\n- Able and willing to follow the protocol requirements.\n- Able to understand and provide written Informed Consent prior to the performance of any study-specific procedure."}

Exclusion criteria

• {"criterion_text":"- Any personal or family history of melanoma or personal history of dysplastic nevus syndrome.\n- Regularly drinks more than four units of alcohol per day.\n- Participation in any clinical study during the six weeks before Screening.\n- Any significant illness prior to the study screening period.\n- Solarium use/sunbathing prior to study involvement and throughout the duration of the study.\n- Not suitable for study participation in the opinion of the Investigator.\n- Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator’s Brochure.\n- Any medical condition which may interfere with the study protocol.\n- Female who is pregnant or lactating.\n- Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.\n- Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.\n- Taking medications that are known photosensitisers.\n- 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."}

Primary endpoints

• {"endpoint_text":"- The changes in UV photoproducts from pre to post afamelanotide in UVR exposed skin and in non-irradiated skin.","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

16-01-2024

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

706

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Clinuvel Europe Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland