InfluenzaPhase 1NCT01313962
Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects
A Phase 1 study testing Flufirvitide-3 0.05 mg single dose, Flufirvitide-3, 0.1 mg single dose and Flufirvitide-3, 0.2 mg single dose in people with Influenza, run by Autoimmune Technologies, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetic profile of flufirvitide-3 nasal spray in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flufirvitide-3 0.05 mg single dose, Flufirvitide-3, 0.1 mg single dose and Flufirvitide-3, 0.2 mg single dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2012
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.
- Healthy male and non-fertile female subjects aged 18 and 55 years inclusive
- Female subjects must have a negative urine pregnancy test at screening must not be lactating or breastfeeding and must be of non-childbearing potential
- Male subjects should be willing to use barrier contraception during sexual intercourse,
- Body weight 50 to 100 kg inclusive and body mass index (BMI) 18 to 30 kg/m2 inclusive.
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- Clinically non-significant findings on physical examination in relation to age.
- Negative Rapid Flu Test (TRU FLU® kit)
- Negative nasal examination upon admission to the study center.
Who cannot join
- History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorders,
- History and/or presence of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Subjects with a surgical history of the gastrointestinal tract should also be excluded from participation in the study.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of the investigational product which is symptomatic enough to affect study conduct or the well-being of the subject
- History and/or presence of asthma or recurrent sinusitis. Active rhinitis at screening or upon admission to the study center.
- Any clinically significant nasal septum deviation, presence of septum perforations, and history of recurrent epistaxis and nasal polyps.
- Subjects with a history of sinus surgery and/or persistent hypertrophic inferior turbinates.
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- History of vaccination with live vaccine within 7 days or attenuated vaccine within 14 days of the administration of the investigational product.
- Any clinically significant abnormalities in clinical laboratory safety assessment results
- A positive result at screening on serum hepatitis B surface antigen, hepatitis C antibodies and HIV antibodies.
- Significant orthostatic reaction at screening or upon admission to the study center as judged by the Principal Investigator.
- Abnormal vital signs, after 5 minutes supine rest,
- Any clinically significant abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (ECG) that may interfere with the interpretation of QTc interval changes.
- Prolonged QTcF greater than 450 ms or shortened QTcF less than 360 ms or family history of long QT syndrome.
- Known or suspected drugs of abuse or alcohol abuse or dependence
- Positive screen for drugs of abuse or alcohol at screening or upon admission to the study center.
- Excessive intake of caffeine-containing foods or beverages within 48 hours prior to the admission to the study center.
- Use of drugs with enzyme-inducing properties such as St John's Wort, within 3 weeks prior to the administration of the investigational product.
- Abstain from smoking from 30 days prior to screening and for the duration of the study.
- Use of any prescribed medication as well as any over-the-counter/non prescribed/ herbal medicines, within 2 weeks prior to administration of the investigational product.
- Use of any nasal steroid 3 months prior to the administration of the investigational product.
- Involvement in the planning and/or conduct of the study
- Have received another new chemical entity or has participated in any other clinical study that included drug treatment within 3 months prior to administration of the investigational product in this study.
- Previous randomization of treatment in the present study or any other study with Flufirvitide-3.
- Plasma donation within 4 weeks prior to enrollment or blood donation
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase One Services
Overland Park, Kansas, 66211
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of Flufirvitide-3 Nasal Spray in Healthy Subjects
The purpose of this study is to evaluate the safety and pharmacokinetic profile of flufirvitide-3 nasal spray in healthy subjects.
- Conditions
- Influenza
- Being tested
- Flufirvitide-3 0.05 mg single dose, Flufirvitide-3, 0.1 mg single dose, Flufirvitide-3, 0.2 mg single dose, Flufirvitide-3, 0.4 mg single dose, Placebo
- Keywords
- antiviral, intranasal, influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flufirvitide-3 0.05 mg single doseDrug
Nasal Spray
Flufirvitide-3, 0.1 mg single doseDrug
Nasal spray
Flufirvitide-3, 0.2 mg single doseDrug
nasal spray
Flufirvitide-3, 0.4 mg single doseDrug
Nasal spray
PlaceboOther
Nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Flufirvitide-3 | Experimental | Not described Receives: Drug: Flufirvitide-3 0.05 mg single dose; Drug: Flufirvitide-3, 0.1 mg single dose; Drug: Flufirvitide-3, 0.2 mg single dose; Drug: Flufirvitide-3, 0.4 mg single dose |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2012
- Study completionJan 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autoimmune Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Hopkins, PhD, Study director, Autoimmune Technologies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313962
- Sponsor's protocol ID
- AIT02-11-01
- Status last verified
- Jan 2012
- First submitted
- 16 Feb 2011
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of Flufirvitide-3 Nasal Spray in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01313962
- Acronym / sponsor ID
- AIT02-11-01
- Conditions
- Influenza
- Keywords
- antiviral, intranasal, influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Autoimmune Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Mar 2011 (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.
The purpose of this study is to evaluate the safety and pharmacokinetic profile of flufirvitide-3 nasal spray in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flufirvitide-3 | Experimental | Drug: Flufirvitide-3 0.05 mg single dose, Drug: Flufirvitide-3, 0.1 mg single dose, Drug: Flufirvitide-3, 0.2 mg single dose, Drug: Flufirvitide-3, 0.4 mg single dose |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.
- Healthy male and non-fertile female subjects aged 18 and 55 years inclusive
- Female subjects must have a negative urine pregnancy test at screening must not be lactating or breastfeeding and must be of non-childbearing potential
- Male subjects should be willing to use barrier contraception during sexual intercourse,
Key exclusion criteria (24 listed)
- History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorders,
- History and/or presence of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Subjects with a surgical history of the gastrointestinal tract should also be excluded from participation in the study.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of the investigational product which is symptomatic enough to affect study conduct or the well-being of the subject
- History and/or presence of asthma or recurrent sinusitis. Active rhinitis at screening or upon admission to the study center.
- Any clinically significant nasal septum deviation, presence of septum perforations, and history of recurrent epistaxis and nasal polyps.
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 |
|---|---|---|
| Flufirvitide-3 0.05 mg single doseNasal Spray | Drug | Flufirvitide-3 |
| Flufirvitide-3, 0.1 mg single doseNasal spray | Drug | Flufirvitide-3 |
| Flufirvitide-3, 0.2 mg single dosenasal spray | Drug | Flufirvitide-3 |
| Flufirvitide-3, 0.4 mg single doseNasal spray | Drug | Flufirvitide-3 |
| PlaceboNasal spray | Other | Placebo |
Primary outcome
Number of Participants with Adverse Events
Time frame: 2 weeks
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 16 Jan 2012.
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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.
Sam Hopkins, PhD study director
Autoimmune Technologies, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flufirvitide-3 0.05 mg single dose, Flufirvitide-3, 0.1 mg single dose and Flufirvitide-3, 0.2 mg single dose in people with Influenza, run by Autoimmune Technologies, LLC 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 9 inclusion and 24 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 16 Jan 2012. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants with Adverse Events (time frame: 2 weeks). 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 16 Jan 2012.