InfluenzaNCT01767337
Intracutaneous Delivery of Varied Dose Volumes of Saline
A study testing FLUGEN 101.2 device in people with Influenza, run by FluGen Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FLUGEN 101.2 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read and/or understand and sign the Informed Consent form
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
An intracutaneous delivery device will be evaluated for ability to inject various volumes of saline into subjects skin.
- Conditions
- Influenza
- Being tested
- FLUGEN 101.2 device
- Keywords
- microneedle-based delivery, hollow microneedle, intracutaneous, drug delivery
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLUGEN 101.2 deviceDevice
Also called FLUGEN 101.2
| Study group | Role | What they receive |
|---|---|---|
| injection of 0.1 mL saline | Experimental | deliver from FluGen 101.2 device Receives: Device: FLUGEN 101.2 device |
| injection of 0.25 mL saline | Experimental | deliver from FluGen 101.2 device Receives: Device: FLUGEN 101.2 device |
| Injection of 0.5 mL saline | Experimental | deliver from FluGen 101.2 device Receives: Device: FLUGEN 101.2 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes, 24 hours, ~ 1 week
Secondary outcomes (1)
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.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- FluGen Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Responsible party
- Sponsor
- Investigators
- Renee Herber, Study director, FluGen IncMurray A Kimmel, DO, Principal investigator, Accelovance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767337
- Sponsor's protocol ID
- FGN-NSR-2012-002
- Status last verified
- Jul 2017
- First submitted
- 9 Jan 2013
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01767337
- Acronym / sponsor ID
- FGN-NSR-2012-002
- Conditions
- Influenza
- Keywords
- microneedle-based delivery, hollow microneedle, intracutaneous, drug delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- FluGen IncIndustry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| injection of 0.1 mL saline | Experimental | Device: FLUGEN 101.2 devicedeliver from FluGen 101.2 device |
| injection of 0.25 mL saline | Experimental | Device: FLUGEN 101.2 devicedeliver from FluGen 101.2 device |
| Injection of 0.5 mL saline | Experimental | Device: FLUGEN 101.2 devicedeliver from FluGen 101.2 device |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Able to read and/or understand and sign the Informed Consent form
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLUGEN 101.2 deviceAlso: FLUGEN 101.2 | Device | Injection of 0.5 mL saline, injection of 0.1 mL saline, injection of 0.25 mL saline |
Primary outcome
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.
1 secondary outcome
A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee Herber study director
FluGen Inc
Murray A Kimmel, DO principal investigator
Accelovance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLUGEN 101.2 device in people with Influenza, run by FluGen Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.