This is a single center, pharmacokinetic and pharmacodynamic study in healthy volunteers.
Twenty four subjects will be enrolled in the study and will be assigned to receive either a
16 mg afamelanotide bioresorbable implant from the current manufacturing process or a 16 mg
afamelanotide bioresorbable implant from the optimized manufacturing process. Implants will
be administered subcutaneously.
The following procedures will be conducted throughout the study:
- Collection of blood samples for analysis of afamelanotide concentrations
- Measurement of skin reflectance for estimation of melanin density, and luminance (L*),
blue/yellow colour hue (b*)
- Safety monitoring