InfluenzaPhase 2NCT02423577

Safety and Protective Efficacy of FF-3 Dry Powder in Healthy Subjects Infected With Influenza Challenge Strain

A Phase 2 study testing FF-3 dry powder in people with Influenza, run by Autoimmune Technologies, LLC at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study are to determine the effect FF-3 in comparison to placebo in subjects who are experimentally inoculated with a live, challenge strain of influenza A virus. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: FF-3 dry powder
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2015to Jun 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and non-pregnant, non-lactating female subjects of 18 to 50 years of age inclusive
Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive and body weight of 50 to 110 kg inclusive.
Normal spirometry values at Screening and Baseline
Post-menopausal women with amenorrhea for at least 2 years will be eligible
Females of childbearing potential must use two acceptable birth control methods throughout the study and for 30 days after the last dose of the IMP:
Male subjects:

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Must agree to use a condom (or diaphragm) plus spermicide in female partner) from the time of the first dose of IMP through 90 days after the last dose.
Must agree to not donate sperm for 90 days after the last dose of IMP.
Documented evidence of vasectomies in males for 180 days minimum prior to the first dose of the IMP is an acceptable form of contraception.
Males who claim abstinence as their method of contraception are allowed provided they agree to use a double barrier method (diaphragm plus spermicide in female partner or condom) should they become sexually active from screening to 90 days after the last dose of IMP.
Willing and able to provide written informed consent.
Willing and able to adhere to the lifestyle guideline restrictions outlined in the protocol

Who cannot join

Subjects may not be enrolled in the study if any of the following exclusion criteria are fulfilled:
Evidence of or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine , or psychiatric disease.
Current infection of any nature unless agreed as insignificant to the study by the Investigator and Medical Monitor.
Nasal abnormalities, including nasal septum deviation, septum perforations, or polyps; history of recurrent epistaxis; history of sinus surgery and/or persistent hypertrophic inferior turbinates.
Significant abnormalities at screening in safety laboratory tests, ECGs, or spirometry.
Broncho-reactive airway disease (asthma, chronic obstructive pulmonary disease, current allergic rhinitis, cystic fibrosis, chronic bronchitis, emphysema). Individuals with a history of childhood asthma are not necessarily excluded and acceptable for screening.

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History of significant nasal irritation from use of nasal sprays or drops.
History of drug or alcohol abuse within the past 2 years
Nicotine product users
Received an investigational drug or participated in another research study within 90 days of the first dose of IMP.
Participated in a previous investigational study of FF-3.
History of influenza vaccination with a live or attenuated vaccine within the previous year
Use of prescription drugs within 14 days prior to the first dose of IMP, excepting oral contraceptives.
Received any non-prescription medications, vitamins, or dietary supplements within 14 days of administration of the first dose of IMP, unless both the Principal Investigator and the Medical Monitor grant prior approval. Herbal supplements must be discontinued 7 days prior to the first dose of IMP.
15. Tested positive for alcohol at screening or admission to the CRU. 16. Positive urine pregnancy test at the Screening Visit or positive serum pregnancy test on admission to the CRU (females only).
17. Positive test for HIV, hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (anti-HCV) at the screening visit.
18. Positive urine drug test at the screening visit or at admission to the CRU. 19. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
20. Subjects who have donated blood or experienced other significant blood loss within 56 days of screening for the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quintiles Drug Research Unit
London

Other trials in United Kingdom

About this study

Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Assessment of the Safety and Protective Efficacy of FF-3 Dry Powder Administered by Nasal Inhalation for 5 Days to Healthy Adult Subjects Who Are Experimentally Infected With a Challenge Strain of Influenza A Virus

The purpose of this study are to determine the effect FF-3 in comparison to placebo in subjects who are experimentally inoculated with a live, challenge strain of influenza A virus.

Conditions: Influenza
Being tested: FF-3 dry powder, Placebo
Keywords: antiviral, influenza, challenge
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FF-3 dry powderDrug
FF-3 dry powder administered by nasal inhalation
PlaceboDrug
Placebo dry powder administered by nasal inhalation

Study groups in NCT02423577
Study group	Role	What they receive
FF-3 dry powder	Experimental	FF-3 Receives: Drug: FF-3 dry powder
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequencies of Viral Shedding
Percentage of Subjects Demonstrating Viral Shedding.
Measured: Day 2 to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Jun 2016

First posted22 Apr 2015 (estimated)
Study startSep 2015
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02423577
Sponsor's protocol ID: AIT02-2001
Other IDs: 2015-001103-31, HHSN272201400003C, DMID 14-0052, 2015
Status last verified: Aug 2017
First submitted: 19 Apr 2015
Last updated: 14 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Assessment of the Safety and Protective Efficacy of FF-3 Dry Powder Administered by Nasal Inhalation for 5 Days to Healthy Adult Subjects Who Are Experimentally Infected With a Challenge Strain of Influenza A Virus
ClinicalTrials.gov ID: NCT02423577
Acronym / sponsor ID: AIT02-2001
Conditions: Influenza
Keywords: antiviral, influenza, challenge
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Autoimmune Technologies, LLCIndustry (pharma, biotech, devices)
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Sep 2015
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 22 Apr 2015 (estimated)
Results: Posted 14 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study are to determine the effect FF-3 in comparison to placebo in subjects who are experimentally inoculated with a live, challenge strain of influenza A virus.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
FF-3 dry powder	Experimental	Drug: FF-3 dry powderFF-3
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy male and non-pregnant, non-lactating female subjects of 18 to 50 years of age inclusive
Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive and body weight of 50 to 110 kg inclusive.
Normal spirometry values at Screening and Baseline
Post-menopausal women with amenorrhea for at least 2 years will be eligible
Females of childbearing potential must use two acceptable birth control methods throughout the study and for 30 days after the last dose of the IMP:

Key exclusion criteria (18 listed)

Subjects may not be enrolled in the study if any of the following exclusion criteria are fulfilled:
15. Tested positive for alcohol at screening or admission to the CRU. 16. Positive urine pregnancy test at the Screening Visit or positive serum pregnancy test on admission to the CRU (females only).
17. Positive test for HIV, hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (anti-HCV) at the screening visit.
18. Positive urine drug test at the screening visit or at admission to the CRU. 19. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
20. Subjects who have donated blood or experienced other significant blood loss within 56 days of screening for the study.

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
FF-3 dry powderFF-3 dry powder administered by nasal inhalation	Drug	FF-3 dry powder
PlaceboPlacebo dry powder administered by nasal inhalation	Drug	Placebo

Primary outcome

Frequencies of Viral Shedding
Time frame: Day 2 to Day 10
Percentage of Subjects Demonstrating Viral Shedding.

Results and safety

Results posted to the registry on 14 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FF-3 Dry Powder	53	53
Placebo	26	26

Primary outcome: Frequencies of Viral Shedding

Time frame: Day 2 to Day 10. Count of participants. Unit: Participants

Measure	FF-3 Dry Powder n = 53	Placebo n = 26
Value	51	22

FF-3 Dry Powder vs Placebo: Risk Ratio (RR): 1.14 (90% CI 0.98 to 1.31), p = 0.1436, Chi-squared

Population analysed: The percentage of subjects demonstrating viral shedding was estimated for each treatment with corresponding asymptotic 95% confidence intervals, based on the normal approximation to the binomial distribution (Wilsons's method)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FF-3 Dry Powder	0 of 53 (0%)	46 of 53 (86.8%)	0 of 53
Placebo	0 of 26 (0%)	23 of 26 (88.5%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FF-3 dry powder in people with Influenza, run by Autoimmune Technologies, LLC at 1 site in United Kingdom.

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 12 inclusion and 18 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 14 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 Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Frequencies of Viral Shedding (time frame: Day 2 to Day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02423577.

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 14 Aug 2017.