Safety Study of Three Formulations of the Dermal Implant ELAPR

A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects

This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.

A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.

Inclusion Criteria:

• Good general health status

Exclusion Criteria:

• Clinically significant abnormalities of haematology or biochemistry testing
• Bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged APTT or PT
• Chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents
• History of keloid formation
• Systemic corticosteroids within last 12 weeks
• Diabetes or metabolic disorders
• Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
• Pregnancy/lactation
• A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine