Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model

-INCLUSION CRITERIA:

• Greater than or equal to 18 and less than or equal to 45 years of age.
• Non-smoker.
• Willingness to remain in isolation for the duration of viral shedding (at a minimum 10 days) and to comply with all study requirements.
• A male subject is eligible for the study if he agrees to practicing abstinence or using a condom with spermicide plus an acceptable form of contraception (see inclusion criteria 5) being used by any female partner from 4 weeks before to 12 weeks after intranasal challenge with influenza.
• A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
• Of nonchildbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
• Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks prior to and 8 weeks after administration of the influenza challenge virus. Acceptable methods of contraception include a male partner who is sterile and is the sole sexual partner of the female participant or a male partner who uses a condom with spermicide plus 1 or more of the following: 1) implants of levonorgestrel; 2) injectable progestogen; 3) an intrauterine device with a documented failure rate of 114kg.
• Acute illness within 7 days of admission and inoculation with the challenge virus (Day -1).
• Complete blood count (CBC) with differential outside of the NIH Department of Laboratory Medicine (DLM) normal reference range and deemed clinically significant by the PI.
• Chemistries in the acute care, mineral, and/or hepatic panels, and/or any of the following: lactate dehydrogenase, uric acid, creatine kinase, and total protein outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• Amylase or Lipase outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• Clinically significant abnormality as deemed by the PI on electrocardiogram.
• Clinically significant abnormality as deemed by the PI on echocardiographic (ECHO) testing.
• Clinically significant abnormality as deemed by the PI on the Pulmonary Function Test (PFT).
• Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals).
• Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).
• Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
• Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
• Receipt of any non-influenza-related unlicensed vaccine within 6 months prior to enrollment.
• Self-reported or known history of current alcoholism or drug abuse, or positive urine/serum test for drugs of abuse and/or ethanol (i.e., amphetamines, cocaine, benzodiazepines, opiates, or metabolites, but not tetrahydrocannabinol (THC) or metabolites).
• Self-reported or known history of psychiatric or psychological issues deemed by the PI to be a contraindication to protocol participation.
• Known close contact with anyone known to have influenza in the past 7 days.
• Known or suspected hypersensitivity to CR6261 or its excipients (sucrose, L-histidine, L-histidine monohydrochloride, polysorbate 20).
• History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
• Drinks more than 1200 mL (or 5 cups of 240 mL per cup) of tea/coffee/cocoa/cola or other caffeinated beverage per day more than 1 day per week in the 2 weeks before screening.
• Any condition or event that, in the judgment of the PI, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent.