Intracutaneous Delivery of Varied Dose Volumes of Saline

Exploratory Evaluation of Healthy Subjects Receiving Varied Dose Volumes of Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01767337

Enrollment

Registered

2013-01-14

Start date

2012-12-31

Completion date

2012-12-31

Last updated

2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

microneedle-based delivery, hollow microneedle, intracutaneous, drug delivery

Brief summary

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.

Detailed description

An intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.

Interventions

DEVICEFLUGEN 101.2 device

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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, presence of 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.

Design outcomes

Primary

Measure	Time frame	Description
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.	30 minutes, 24 hours, ~ 1 week	Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent resolution.

Secondary

Measure	Time frame	Description
A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.	3 minutes	Evaluate ability of device to dispense targeted dose volume.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026