Site Selection for Intracutaneous Saline Delivery

FluGen Inc12 enrolled

Overview

The goal of this exploratory study is to select the optimal body site for intracutaneous delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.

Test ability to inject saline into various sites on body.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Intracutaneous Drug Delivery

Interventions

Injection to deltoidDEVICE

Deliver 0.5 milliliters of saline intradermally

Injection to forearmDEVICE

Deliver 0.5 milliliters of saline intradermally

Injection to thighDEVICE

Deliver 0.5 milliliters of saline intradermally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Able to read and/or understand and sign the Informed Consent Form Exclusion Criteria: * Medical history of acute or chronic skin disease * Active skin allergy or acute skin infection, tattoo(s), scars, sunburn or skin abnormalities at any prospective injection site * Hirsute at any prospective injection site * Diabetes * High levels of anxiety or depression or history of psychosis * Abuse of alcohol or use of other drugs of abuse including tobacco * Pregnant or breastfeeding women * Any medical condition that may interfere with study protocol adherence including completion of study activities * Foreseeable inability to complete the study as scheduled.

Locations (1)

Accelovance Inc

Melbourne, Florida, United States

Outcomes

Primary Outcomes

The primary objective is to evaluate the safety and tolerability/reactogenicity of saline delivery 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 wheal formation or resolution.

Time frame: 30 minutes, 24 hours, 1 week

Secondary Outcomes

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

Data from ClinicalTrials.gov

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