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b'physical examination, vital signs, and 12-lead electrocardiogram (ECG).'
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b'If the subject has another current, ongoing chronic medical condition, the'
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b'condition cannot: (i) Be first diagnosed within 3 months of enrollment; or (ii)'
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b'Have worsened in terms of clinical outcome in the first 3 months; or (iii)'
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b"Involve the need for medication that may pose a risk to the subject's safety or"
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b'impede assessment of adverse events (AEs) or anti-AV-1 antibody response if they'
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b'participate in the study.'
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b'Women who are not pregnant and/or not lactating.'
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b'Female subjects, including postmenopausal women and surgically sterile women, must'
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b'have a negative serum pregnancy test at Screening, Check-in and on admission to the'
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b'tudy facility.'
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b'Female subjects must fulfill one of the following criteria:'
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b'Postmenopausal women must have had \\u2265 12 months of spontaneous amenorrhea with'
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b'follicle-stimulating hormone concentration consistently \\u226540 mIU/mL and must have'
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b'a negative pregnancy test result at Screening and Check-in.'
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b'Surgically sterile women - those who have had a hysterectomy, bilateral'
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b'ovariectomy (oophorectomy), or bilateral tubal ligation, must provide'
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b'documentation of the procedure and must have a negative pregnancy test at'
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b'Screening and Check-in.'
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b'Must be willing to not engage in sexual intercourse from Check-in until the final'
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b'follow-up visit on Day 85 (\\xb1 5 days).'
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b'Must be willing to use an acceptable method of birth control until the final'
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b'follow-up visit on Day 85 (\\xb1 5 days) as defined by the protocol and Investigator.'
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b'Male subjects who are biologically capable of fathering children must agree and commit'
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b'to using an adequate form of double-barrier contraception, and refrain from sperm'
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b'donation from Check-in until the final follow-up visit on Day 85 (\\xb1 5 days). A male'
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b'ubject is considered capable of fathering children even if his sexual partner is'
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b'terile or using contraceptives.'
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b'Body Mass Index between 13.5 and 29.9 kg/m^2 inclusive.'
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b'Must not have traveled outside the USA within 60 days prior to Check-in, and agree not'
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b'to travel outside the USA through the final follow-up visit on Day 85 (\\xb1 5 days).'
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b'Must agree to abide by study restrictions and be willing to sign an informed consent'
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b'form.'
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b'Any significant medical condition that, in the opinion of the Investigator or Sponsor,'
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b"would interfere with the subject's ability to participate in the study or increase the"
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b"risk of participating for that subject, based on the Investigator's Brochure and the"
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b'afety profile of AV-1.'
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b'Subject has one or more symptoms of a urinary tract infection (e.g. dysuria, frequent,'
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b'urgency, or suprapubic pain) at Screening or Check-in.'
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b'Has certain abnormal12-lead ECG (electrocardiogram) results according to the protocol,'
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b'as assessed by the Investigator.'
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b'Has abnormal laboratory values for certain hematology, serum chemistry, coagulation,'
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b'or urinalysis tests according to the protocol, as assessed by the Investigator.'
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b'Is positive for hepatitis B surface antigen, hepatitis C virus antibody, or human'
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b'immunodeficiency virus (HIV) antibody types 1 and 2 within 28 days of enrollment.'
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b'Has any psychiatric condition or history of psychiatric condition that, in the opinion'
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b"of the Investigator or Sponsor, would interfere with the subject's ability to"
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b'participate in the study or increase the risk of participation for that subject.'
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b'Is unwilling to abstain from alcohol, caffeine-, or other xanthine-containing foods or'
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b'beverages, tobacco or nicotine-containing products, and all bergamottin-containing'
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b'fruits and fruit juices (e.g. Seville oranges, grapefruit/grapefruit juice, pomelos,'
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b'pomegranate/pomegranate juice, cranberries/cranberry juice) 72 hours prior to'
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b'Check-in, through discharge on Day 5 of the study.'
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b'Is unwilling to abstain from strenuous exercise 7 days before Check-in through Day 15'
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b'of the study.'
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b'Has a history of alcoholism or drug/chemical abuse within 6 months prior to Check-in.'
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b'Has excessive alcohol consumption (regular alcohol intake >21 units per week for male'
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b'ubjects and >14 units of alcohol per week for female subjects) (1 unit is equal to'
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b'approximately 1/2 pint [200 mL] beer, 1 small glass [100 mL] wine, or 1 measure [25'
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b'mL] spirits).'
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b'Has any confirmed or suspected immunosuppressive or immunodeficient condition,'
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b'including but not limited to human immunodeficiency virus infection, or use of'
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b'anti-cancer chemotherapy or radiation therapy (cytotoxic) in the 3 years prior to'
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b'Screening.'
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b'Provides verbal history of vaccination with a licensed or investigational flavivirus'
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b'vaccine for any of the following diseases: Zika virus, DENV, yellow fever virus,'
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b'Japanese encephalitis virus, West Nile virus, St. Louis encephalitis virus, or'
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b'tick-borne encephalitis virus; or reportedly diagnosed with a flavivirus infection or'
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b'disease.'
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b'Plans to receive a licensed flavivirus vaccine or participate in flavivirus vaccine'
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b'trial during the study.'
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b'Has had major surgery within 3 months prior to Screening or plans to have major'
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b'urgery during the study through the final follow-up on Day 85 (\\xb1 5 days).'
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b'Has been treated for a medical condition with a licensed monoclonal or polyclonal'
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b'antibody in the past; or dosed in a clinical study involving administration of an'
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b'investigational monoclonal or polyclonal antibody in the 18 months prior to study drug'
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b'administration on Day 1.'
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b'Has received an investigational drug within 28 days of study drug administration on'
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b'Day 1.'
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b'Has used any prohibited medication within 30 days prior to Check-in, or plans to use'
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b'prohibited medication during the study. Prohibited medications include:'
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b'Immunosuppressive drugs, immune modulators (except acetaminophen), oral'
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b'corticosteroids, inhaled or intranasal steroids (<800 \\xb5g/day beclomethasone is'
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b'acceptable), and anti-neoplastic agents. Topical steroids are acceptable.'
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b'Has received or plans to receive any live vaccination, experimental or otherwise,'
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b'within 28 days prior to or after Day 1 of the study; and receipt or planned receipt of'
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b'an inactivated vaccination, experimental or otherwise, within 14 days prior to or'
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b'after Day 1 of the study.'
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b'Has received blood products within 60 days prior to Check-in.'
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b'Has donated or lost more than 450 mL of blood or plasma within 56 days of study drug'
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b'infusion on Day 1. The subject must also agree to refrain from donating blood or'
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b'plasma during the study.'
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b'Other protocol-defined inclusion/exclusion criteria may apply.'
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