- Subject must be in good health at Screening (reaffirmed at Check-in):
1. Good health is defined by the absence of a medical condition described in the
exclusion criteria of the study protocol, and based on screening medical history,
physical examination, vital signs, and 12-lead electrocardiogram (ECG).
2. If the subject has another current, ongoing chronic medical condition, the
condition cannot: (i) Be first diagnosed within 3 months of enrollment; or (ii)
Have worsened in terms of clinical outcome in the first 3 months; or (iii)
Involve the need for medication that may pose a risk to the subject's safety or
impede assessment of adverse events (AEs) or anti-AV-1 antibody response if they
participate in the study.
- Women who are not pregnant and/or not lactating.
- Female subjects, including postmenopausal women and surgically sterile women, must
have a negative serum pregnancy test at Screening, Check-in and on admission to the
- Female subjects must fulfill one of the following criteria:
1. Postmenopausal women must have had â‰¥ 12 months of spontaneous amenorrhea with
follicle-stimulating hormone concentration consistently â‰¥40 mIU/mL and must have
a negative pregnancy test result at Screening and Check-in.
2. Surgically sterile women - those who have had a hysterectomy, bilateral
ovariectomy (oophorectomy), or bilateral tubal ligation, must provide
documentation of the procedure and must have a negative pregnancy test at
Screening and Check-in.
3. Must be willing to not engage in sexual intercourse from Check-in until the final
follow-up visit on Day 85 (Â± 5 days).
4. Must be willing to use an acceptable method of birth control until the final
follow-up visit on Day 85 (Â± 5 days) as defined by the protocol and Investigator.
- Male subjects who are biologically capable of fathering children must agree and commit
to using an adequate form of double-barrier contraception, and refrain from sperm
donation from Check-in until the final follow-up visit on Day 85 (Â± 5 days). A male
subject is considered capable of fathering children even if his sexual partner is
sterile or using contraceptives.
- Body Mass Index between 13.5 and 29.9 kg/m^2 inclusive.
- Must not have traveled outside the USA within 60 days prior to Check-in, and agree not
to travel outside the USA through the final follow-up visit on Day 85 (Â± 5 days).
- Must agree to abide by study restrictions and be willing to sign an informed consent
- Any significant medical condition that, in the opinion of the Investigator or Sponsor,
would interfere with the subject's ability to participate in the study or increase the
risk of participating for that subject, based on the Investigator's Brochure and the
safety profile of AV-1.
- Subject has one or more symptoms of a urinary tract infection (e.g. dysuria, frequent,
urgency, or suprapubic pain) at Screening or Check-in.
- Has certain abnormal12-lead ECG (electrocardiogram) results according to the protocol,
as assessed by the Investigator.
- Has abnormal laboratory values for certain hematology, serum chemistry, coagulation,
or urinalysis tests according to the protocol, as assessed by the Investigator.
- Is positive for hepatitis B surface antigen, hepatitis C virus antibody, or human
immunodeficiency virus (HIV) antibody types 1 and 2 within 28 days of enrollment.
- Has any psychiatric condition or history of psychiatric condition that, in the opinion
of the Investigator or Sponsor, would interfere with the subject's ability to
participate in the study or increase the risk of participation for that subject.
- Is unwilling to abstain from alcohol, caffeine-, or other xanthine-containing foods or
beverages, tobacco or nicotine-containing products, and all bergamottin-containing
fruits and fruit juices (e.g. Seville oranges, grapefruit/grapefruit juice, pomelos,
pomegranate/pomegranate juice, cranberries/cranberry juice) 72 hours prior to
Check-in, through discharge on Day 5 of the study.
- Is unwilling to abstain from strenuous exercise 7 days before Check-in through Day 15
of the study.
- Has a history of alcoholism or drug/chemical abuse within 6 months prior to Check-in.
- Has excessive alcohol consumption (regular alcohol intake >21 units per week for male
subjects and >14 units of alcohol per week for female subjects) (1 unit is equal to
approximately 1/2 pint [200 mL] beer, 1 small glass [100 mL] wine, or 1 measure [25
- Has any confirmed or suspected immunosuppressive or immunodeficient condition,
including but not limited to human immunodeficiency virus infection, or use of
anti-cancer chemotherapy or radiation therapy (cytotoxic) in the 3 years prior to
- Provides verbal history of vaccination with a licensed or investigational flavivirus
vaccine for any of the following diseases: Zika virus, DENV, yellow fever virus,
Japanese encephalitis virus, West Nile virus, St. Louis encephalitis virus, or
tick-borne encephalitis virus; or reportedly diagnosed with a flavivirus infection or
- Plans to receive a licensed flavivirus vaccine or participate in flavivirus vaccine
trial during the study.
- Has had major surgery within 3 months prior to Screening or plans to have major
surgery during the study through the final follow-up on Day 85 (Â± 5 days).
- Has been treated for a medical condition with a licensed monoclonal or polyclonal
antibody in the past; or dosed in a clinical study involving administration of an
investigational monoclonal or polyclonal antibody in the 18 months prior to study drug
administration on Day 1.
- Has received an investigational drug within 28 days of study drug administration on
- Has used any prohibited medication within 30 days prior to Check-in, or plans to use
prohibited medication during the study. Prohibited medications include:
Immunosuppressive drugs, immune modulators (except acetaminophen), oral
corticosteroids, inhaled or intranasal steroids (<800 Âµg/day beclomethasone is
acceptable), and anti-neoplastic agents. Topical steroids are acceptable.
- Has received or plans to receive any live vaccination, experimental or otherwise,
within 28 days prior to or after Day 1 of the study; and receipt or planned receipt of
an inactivated vaccination, experimental or otherwise, within 14 days prior to or
after Day 1 of the study.
- Has received blood products within 60 days prior to Check-in.
- Has donated or lost more than 450 mL of blood or plasma within 56 days of study drug
infusion on Day 1. The subject must also agree to refrain from donating blood or
plasma during the study.
Other protocol-defined inclusion/exclusion criteria may apply.