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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001103-31 | EudraCT Number | ||
| HHSN272201400003C | Other Grant/Funding Number | National Institute of Health, NIAID | |
| DMID 14-0052 | Other Identifier | Division of Microbiology and Infectious Diseases |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FF-3 dry powder | Experimental | FF-3 |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FF-3 dry powder | Drug | FF-3 dry powder administered by nasal inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequencies of Viral Shedding | Percentage of Subjects Demonstrating Viral Shedding. | Day 2 to Day 10 |
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Inclusion Criteria:
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:
Willing and able to provide written informed consent.
Willing and able to adhere to the lifestyle guideline restrictions outlined in the protocol
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Drug Research Unit | London | United Kingdom |
Potential subjects were screened to determine their susceptibility to infection with the challenge strain as indicated by a serum antibody titre less than 1:10. Only subjects susceptible to the challenge strain qualified for study specific screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | FF-3 Dry Powder | FF-3 FF-3 dry powder: FF-3 dry powder administered by nasal inhalation |
| FG001 | Placebo | Placebo: Placebo dry powder administered by nasal inhalation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FF-3 Dry Powder | FF-3 FF-3 dry powder: FF-3 dry powder administered by nasal inhalation |
| BG001 | Placebo | Placebo: Placebo dry powder administered by nasal inhalation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequencies of Viral Shedding | Percentage of Subjects Demonstrating Viral Shedding. | 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) | Posted | Count of Participants | Participants | Day 2 to Day 10 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FF-3 Dry Powder | FF-3 FF-3 dry powder: FF-3 dry powder administered by nasal inhalation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell Wilson, PhD | President and Chief Scientific Officer | 504-896-2789 | rbw@autoimmune.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo |
| Drug |
Placebo dry powder administered by nasal inhalation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 46 |
| 53 |
| EG001 | Placebo | Placebo: Placebo dry powder administered by nasal inhalation | 0 | 26 | 0 | 26 | 23 | 26 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Lethargy | Nervous system disorders |
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| Headache | Nervous system disorders |
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| Dysgeusia | Nervous system disorders |
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| Restless Legs Syndrome | Nervous system disorders |
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| Eye pain | Eye disorders |
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| Influenza Like Illness | General disorders |
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| Vessel Puncture Site Haematoma | General disorders |
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| Fatigue | General disorders |
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| Medical device site rash | General disorders |
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| Feeling Hot | General disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Nausea | General disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Pruritis | Skin and subcutaneous tissue disorders |
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| Back Pain | Musculoskeletal and connective tissue disorders |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders |
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| Myalgia | Musculoskeletal and connective tissue disorders |
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| Paraesthesia | Musculoskeletal and connective tissue disorders |
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| Otitis Media | Infections and infestations |
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| Conjunctivitis | Infections and infestations |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |