Intracutaneous Delivery of Varied Dose Volumes of Saline

F

FluGen

Status

Completed

Conditions

Influenza

Treatments

Device: FLUGEN 101.2 device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01767337
FGN-NSR-2012-002

Details and patient eligibility

About

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.

Full description

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

Enrollment

24 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 3 patient groups

injection of 0.1 mL saline
Experimental group
Description:
deliver from FluGen 101.2 device
Treatment:
Device: FLUGEN 101.2 device
injection of 0.25 mL saline
Experimental group
Description:
deliver from FluGen 101.2 device
Treatment:
Device: FLUGEN 101.2 device
Injection of 0.5 mL saline
Experimental group
Description:
deliver from FluGen 101.2 device
Treatment:
Device: FLUGEN 101.2 device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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