EUCTR2015-001103-31-GB进行中（未招募）1 期
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 - AIT02-2001 Safety and Protective Efficacy Study of FF-3 Dry Powder
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 79
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Healthy male and non-pregnant, non-lactating female subjects of 18 to 50 years of age inclusive. Subjects must not be over 50 years of age at the 30-Day follow up.
- •2. Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive and body weight of 50 to 110 kg inclusive.
- •3. Normal spirometry values at Screening and Baseline defined as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) greater than or equal to 80% predicted or above the LLN and the FEV1/FVC ratio greater than or equal to 70%.
- •4. Post-menopausal women with amenorrhea for at least 2 years will be eligible (confirmed by follicle stimulating hormone [FSH] test).
- •5. Females of childbearing potential must use two of the following acceptable birth control methods throughout the study and for 30 days after the last dose of the IMP:
- •(a) Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to the first dose of the IMP.
- •(b) Intrauterine device (IUD) in place for at least 90 days prior to the first dose of the IMP.
- •(c) Barrier methods (diaphragm plus spermicide or condom) starting at least 14 days prior to the first dose of the IMP.
- •(d) Abstinence (the subject must be willing to remain abstinent from screening to 30 days after the last dose of IMP).
- •(e) Surgical sterilization of partner(s) (vasectomy) for =180 days prior to the first dose of the IMP.
- •(f) Hormonal contraceptives starting =90 days prior to the first dose of the IMP. If hormonal contraceptives are started <90 days prior to the first dose of IMP, subjects must agree to use a barrier method (diaphragm plus spermicide or condom) from screening through 90 days after initiation of hormonal contraceptives.
- •6. Male subjects:
- •(a) 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.
- •(b) Must agree to not donate sperm for 90 days after the last dose of IMP.
- •(c) Documented evidence of vasectomies in males for 180 days minimum prior to the first dose of the IMP is an acceptable form of contraception.
- •(d) 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.
- •7. Willing and able to provide written informed consent.
- •8. Willing and able to adhere to the lifestyle guideline restrictions outlined in the protocol.
- •9. Willing and able to be confined to the Clinical Research Unit (CRU) as required by the protocol.
- •10. Evidence of HAI antibody titer (i.e., less than 1:10) at Panel Screening (to be conducted under protocol number QLON-2011-SCR-01; DMID protocol number 15-0030) that indicates that the subject will be susceptible to infection with the challenge strain. The HAI titer will be assessed at Study Specific Screening only if the subject exhibits signs of respiratory infection at the Study Specific Screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
排除标准
- •1. Evidence of or history of clinically significant oncologic, pulmonary (e.g., chronic bronchitis, chronic obstructive pulmonary disease), hepatic (e.g., hepatitis, cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease), gastrointestinal, cardiovascular (e.g., congestive heart failure, congenital heart disease, coronary artery disease), hematologic (e.g., sickle cell anemia), metabolic (e.g., Gaucher’s Disease, glucose malabsorption, phenylketonuria), neurological (e.g., cerebral palsy, epilepsy, stroke, seizures), immunologic (e.g., HIV infection, chronic immunosuppressive medication), nephrologic (e.g., bacterial infection, kidney stones), endocrine (e.g., diabetes mellitus), or psychiatric disease
- •2. Current infection of any nature unless agreed as insignificant to the study by the Investigator and Medical Monitor. Evidence of concurrent respiratory infection as determined by a rapid diagnostic test with the FilmArray™ Respiratory Panel from BioFire Diagnostics, Inc.
- •3. Nasal abnormalities, including nasal septum deviation, septum perforations, or polyps; history of recurrent epistaxis; history of sinus surgery and/or persistent hypertrophic inferior turbinates.
- •4. Significant abnormalities at screening in safety laboratory tests, ECGs, or spirometry as defined by Quintiles SOPs.
- •5. Inability to perform spirometry according to the 2005 American Thoracic Society (ATS) acceptability and repeatability standards.
- •6. 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 acceptable for screening.
- •7. History of significant nasal irritation from use of nasal sprays or drops.
- •8. History of drug or alcohol abuse within the past 2 years; current excessive user of alcohol defined as regular weekly intake of greater than 21 units for male subjects and 14 units for female subjects. One unit equals 25 mL spirits, 125 mL wine or 250 mL beer.
- •9. Nicotine product users (includes users who stopped smoking ?90 days prior to the screening evaluation and 30 days prior to the first dose of IMP). [Note: Nicotine use” includes smoking and the use of snuff, e-cigarettes, and chewing tobacco, and other nicotine or nicotine containing products.]
- •10. Received an investigational drug or participated in another research study within 90 days of the first dose of IMP.
- •11. Participated in a previous investigational study of FF-3.
- •12. History of influenza vaccination with a live or attenuated vaccine within the previous year prior to experimental inoculation on Study Day 1.
- •13. Use of prescription drugs within 14 days prior to the first dose of IMP, excepting oral contraceptives.
- •14. 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. Use of antihistamines and/or decongestants within 30 days, nasal corticosteroids within 90 days, or systemic corticosteroids within 90 days prior to the first dose of IMP
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