Healthy Clinical Trial
Official title:
A Phase Ib Study to Confirm the Pharmacokinetics and Melanogenic Potential of Controlled-Release Bioresorbable Implants of Afamelanotide in Healthy Volunteers
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
The objective of the proposed study is to confirm that the pharmacokinetic and
pharmacodynamic properties of implants eluting 16 mg of afamelanotide produced by this final
optimized manufacturing process are essentially the same as those of implants manufactured
with the same formulation that have been used in earlier clinical studies
The study will involve the use of an implant, which comes in the form of a small rod to be
administered under the skin.
For this study, afamelanotide has been formulated as a controlled release depot injection
(implant). This means that the afamelanotide will be released slowly into the body over a few
days. Once inserted, the implant will remain in the body after afamelanotide has been
released and will slowly dissolve.
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