Performance and Safety Evaluation of an Intradermal Delivery Device

Phase I Performance and Safety Evaluation of an Intradermal Delivery Device

The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.

Inclusion Criteria:

• Female and male participants ages 18 to 55 years.
• Healthy enough to participate in the clinical trial per site investigator assessment.
• Healthy skin on the upper deltoid region of both arms.
• Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
• Literate in English.
• Available by telephone 48 hours after the study visit.

Exclusion Criteria:

• Skin abnormalities on upper deltoid region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
• Unable to understand the study purpose or procedures.