Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
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:
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.
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.
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).
Positive test for 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. 19. 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.
Primary purpose
Allocation
Interventional model
Masking
79 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal