Performance and Safety Evaluation of an Intradermal Delivery Device

People Acting To Help (PATH)

Status and phase

Completed

Phase 1

Conditions

Injections, Intradermal

Treatments

Device: PATH ID Adapter

Study type

Interventional

Funder types

Other

Identifiers

NCT01359111

HS 563

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.