InfluenzaPhase 1NCT01990846
Safety, Tolerability, and PK of Escalating Doses of Flufirvitide-3 Dry Powder for Inhalation in Healthy Subjects
A Phase 1 study testing Flufirvitide 3 in people with Influenza, run by Autoimmune Technologies, LLC at 1 site in United States.
Trial summary
To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects 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?
- Flufirvitide 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2015
- 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 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 30 kg/m2 inclusive and body weight of 50 to 100 kg inclusive.
- Normal spirometry values at Screening and Baseline defined as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) greater than 80% predicted or above the LLN and the FEV1/FVC ratio greater than 70%. Results of FEV1 and FVC must be reproducible (± 5%) between Screening and Baseline.
- Post-menopausal women with amenorrhea for at least 2 years will be eligible (confirmed by follicle stimulating hormone [FSH] test).
- Females of childbearing potential must use 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.
- Vasectomies in males for 6 months minimum prior to the first dose of the IMP are an acceptable form of contraception.
- Males who claim abstinence as their method of contraception are allowed provided they agree to use a 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 and provide authorization for use of protected health information (HIPAA).
- Willing and able to adhere to the lifestyle guideline restrictions outlined in the protocol.
- Willing and able to be confined to the CRU as required by the protocol.
Who cannot join
- Evidence of or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, or psychiatric disease, or current clinically significant infection.
- History and/or presence of asthma at Screening or Baseline; presence of active rhinitis or sinusitis at Screening or Baseline.
- Clinically significant nasal abnormalities including nasal septum deviation, septum perforations, or polyps, history of recurrent epistaxis, history of sinus surgery and/or persistent hypertrophic inferior turbinates.
- Clinically significant abnormalities at Screening or Baseline in safety laboratory tests, ECGs, or spirometry.
- Inability to perform spirometry according to the 2005 American Thoracic Society (ATS) acceptability and repeatability standards.
- History of significant nasal irritation from use of nasal sprays or drops.
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- Corrected QT interval (QTc) greater than 450 msec for males and 470 msec for females as corrected by the Fridericia formula.
- History of drug or alcohol abuse within the past 2 years; current excessive user of alcohol defined as regular weekly intake of greater than 15 units for male subjects and 10 units for female subjects. One unit equals 25 mL spirits, 125 mL wine or 250 mL beer.
- Tobacco users (includes users who stopped smoking £90 days prior to the screening evaluation). [Note: "Tobacco use" includes smoking and the use of snuff and chewing tobacco, and other nicotine or nicotine containing products.]
- Received an IMP or participated in another research study within 30 days of the first dose of the IMP for this study.
- Participated in a previous investigational study of FF3.
- History of influenza vaccination with a live vaccine within 7 days or with an attenuated vaccine within 14 days of the first dose of IMP.
- 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 7 days of administration of the first dose of IMP, unless prior approval is granted by both the Principal Investigator and the Medical Monitor. Excluded from this list is intermittent use of acetaminophen £2 g/day or ibuprofen £1200 mg/day. Herbal supplements must be discontinued 14 days prior to the first dose of IMP.
- Use of any antihistamines and/or decongestants within 30 days or nasal corticosteroids within 3 months prior to the first dose of IMP.
- Consumed alcohol within 72 hours of Day -1 or have a positive alcohol test at Screening or admission to the CRU.
- Subjects who consumed grapefruit juice or juices containing grapefruit or ate grapefruit or ate Seville oranges within 7 days prior to the first dose of IMP.
- Excessive intake of caffeine-containing foods or beverages (more than 5 units or equivalent per day) within 48 hours prior to the admission to the study center (Day 1). One caffeine unit is contained in the following items: 1 (6 oz) cup of coffee, 2 (12 oz) cans of cola, 1 (12 oz) glass of tea, ½ (4 oz) cup of energy drink (e.g., Red Bull) or 3 (1 oz) chocolate bars.
- Positive serum pregnancy test at the Screening Visit or positive urine pregnancy test on Day 1 (females only).
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (anti-HCV) at the Screening Visit.
- Positive urine drug test at the Screening Visit or at admission to the CRU.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
- Subjects who have donated blood or experienced other significant blood loss within 56 days of screening for the study.
- Subjects with hemoglobin (Hb) <11 g/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Doses of Flufirvitide-3 Dry Powder for Inhalation in Healthy Subjects
To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects
- Conditions
- Influenza
- Being tested
- Flufirvitide 3, Placebo for Flufirvitide-3
- Keywords
- antiviral, 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 3Drug
Also called FF-3
Placebo for Flufirvitide-3Drug
| Study group | Role | What they receive |
|---|---|---|
| Flufirvitide-3 dose level 1 | Experimental | Single dose administration for dose level 1 Receives: Drug: Flufirvitide 3 |
| Flufirvitide 3-Dose level 2 | Experimental | Single dose administration for Dose Level 2 Receives: Drug: Flufirvitide 3 |
| Placebo | Placebo comparator | Single Dose administration Placebo for Flufirvitide-3 Receives: Drug: Placebo for Flufirvitide-3 |
| Flufirvitide-3 Dose level 1- Repeat dose | Experimental | Repeat dose administration for five days Receives: Drug: Flufirvitide 3 |
| Flufirvitide-3-Dose level 2 Repeat dose | Experimental | Repeat dose administration for 5 days Receives: Drug: Flufirvitide 3 |
| Placebo for Flufirvitide-3 Repeat dose | Placebo comparator | Repeat dose administration for 5 days Receives: Drug: Placebo for Flufirvitide-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adverse events from Baseline
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autoimmune Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990846
- Sponsor's protocol ID
- AIT02-1002
- Status last verified
- Mar 2015
- First submitted
- 18 Nov 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. 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 and Repeat Doses of Flufirvitide-3 Dry Powder for Inhalation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01990846
- Acronym / sponsor ID
- AIT02-1002
- Conditions
- Influenza
- Keywords
- antiviral, influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Autoimmune Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Nov 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.
To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Flufirvitide-3 dose level 1 | Experimental | Drug: Flufirvitide 3Single dose administration for dose level 1 |
| Flufirvitide 3-Dose level 2 | Experimental | Drug: Flufirvitide 3Single dose administration for Dose Level 2 |
| Placebo | Placebo comparator | Drug: Placebo for Flufirvitide-3Single Dose administration Placebo for Flufirvitide-3 |
| Flufirvitide-3 Dose level 1- Repeat dose | Experimental | Drug: Flufirvitide 3Repeat dose administration for five days |
| Flufirvitide-3-Dose level 2 Repeat dose | Experimental | Drug: Flufirvitide 3Repeat dose administration for 5 days |
| Placebo for Flufirvitide-3 Repeat dose | Placebo comparator | Drug: Placebo for Flufirvitide-3Repeat dose administration for 5 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 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 30 kg/m2 inclusive and body weight of 50 to 100 kg inclusive.
- Normal spirometry values at Screening and Baseline defined as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) greater than 80% predicted or above the LLN and the FEV1/FVC ratio greater than 70%. Results of FEV1 and FVC must be reproducible (± 5%) between Screening and Baseline.
- Post-menopausal women with amenorrhea for at least 2 years will be eligible (confirmed by follicle stimulating hormone [FSH] test).
- Females of childbearing potential must use acceptable birth control methods throughout the study and for 30 days after the last dose of the IMP:
Key exclusion criteria (24 listed)
- Evidence of or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, or psychiatric disease, or current clinically significant infection.
- History and/or presence of asthma at Screening or Baseline; presence of active rhinitis or sinusitis at Screening or Baseline.
- Clinically significant nasal abnormalities including nasal septum deviation, septum perforations, or polyps, history of recurrent epistaxis, history of sinus surgery and/or persistent hypertrophic inferior turbinates.
- Clinically significant abnormalities at Screening or Baseline in safety laboratory tests, ECGs, or spirometry.
- Inability to perform spirometry according to the 2005 American Thoracic Society (ATS) acceptability and repeatability standards.
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 3Also: FF-3 | Drug | Flufirvitide 3-Dose level 2, Flufirvitide-3 Dose level 1- Repeat dose, Flufirvitide-3 dose level 1, Flufirvitide-3-Dose level 2 Repeat dose |
| Placebo for Flufirvitide-3 | Drug | Placebo, Placebo for Flufirvitide-3 Repeat dose |
Primary outcome
Change in adverse events from Baseline
Time frame: 8 days
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 11 Mar 2015.
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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 1 study testing Flufirvitide 3 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 13 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 11 Mar 2015. 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?
Change in adverse events from Baseline (time frame: 8 days). 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 11 Mar 2015.