This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of saline from the FLUGEN 101.2 investigational microneedle-based device.
An intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
Accelovance Inc
Melbourne, Florida, United States
The primary objective is to evaluate the safety and tolerability/reactogenicity of various saline volumes delivered from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time.
Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent resolution.
Time frame: 30 minutes, 24 hours, ~ 1 week
A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.
Evaluate ability of device to dispense targeted dose volume.
Time frame: 3 minutes
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