Implant Pharmacokinetic and Pharmacodynamic Study

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.

Inclusion Criteria:

- Healthy Caucasian adults aged between 18 and 45 years (inclusive).

- Free of significant abnormal findings as determined during the screening procedure by
surgical and medical history, physical examination, ECG, clinical laboratory testing
and vital signs.

- BMI between 18 and 30 kg/m2 (inclusive).

- No history of drug abuse, licit or illicit (including alcohol).

- Agree not to use any medications (prescribed medicines, over-the-counter medications,
dietary supplements or nutraceuticals) without pre-approval by the Principal
Investigator or nominee during the 7 days preceding the study, and during the course
of the study (until Day 60)

- Willing to take precautions to prevent pregnancy until completion of the study (Day
60).

- Able to understand and sign the written Informed Consent Form.

- Able and willing to follow the Protocol requirements, including refraining from the
use of melanogenic (tanning) products and recreational sun or UV light exposure from
the start of the study until Day 60

Exclusion Criteria:

- Any significant history of allergy and/or sensitivity to any of the contents of study
drug product.

- Any significant history of allergy and/or sensitivity to lignocaine or other local
anaesthetic.

- Any evidence of organ dysfunction or any clinically significant deviation from normal
in the physical or clinical determinations.

- Personal history of melanoma, dysplastic nevus syndrome or family history of melanoma
in a first degree relative.

- Any evidence at the screening medical examination of hypertension or hypotension.
Hypertension is defined as three separate readings that persistently read over 140/90
mmHg systolic/diastolic. Hypotension is defined as three separate readings that
persistently read under 90/50 mmHg systolic/diastolic.

- A pulse rate of less than 50 beats/minute.

- Any significant illness during the 4 weeks before the study screening period.

- Any contraindication to blood sampling.

- Any factor that may interfere with the skin reflectance measurements (e.g. vitiligo,
albinism, excessive number of moles, or excessively hairy skin).

- Positive screening urine drugs of abuse test.

- Participation in any clinical study during the 4 weeks before the study screening
period.

- Has donated 400 mL or more of blood or had significant blood loss during the 8 weeks
preceding screening.

- Has donated plasma within the 7 days preceding screening.

- Have consumed alcohol during the 24 hours prior to Day 1