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Completed

NCT Number: NCT01767337

Intracutaneous Delivery of Varied Dose Volumes of Saline

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Accelovance Inc

Melbourne, Florida, 32935, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FLUGEN 101.2 device

Device

Other names: FLUGEN 101.2

Primary outcomes

  1. 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.

    Time frame: 30 minutes, 24 hours, ~ 1 week

    Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent resolution.

Secondary outcomes

  1. A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.

    Time frame: 3 minutes

    Evaluate ability of device to dispense targeted dose volume.

Sponsors and collaborators

Lead sponsor

FluGen Inc

Industry

Collaborators

  • Accelovance

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 14, 2013
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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