A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers

Inclusion Criteria

• Subject must be in good health at Screening (reaffirmed at Check-in):
• 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).
• If the subject has another current, ongoing chronic medical condition, the condition cannot: (i) Be first diagnosed within 3 months of enrollment; or (ii) Be a pre-existing medical condition that is not exclusionary but has worsened in terms of clinical outcome within 3 months of enrollment; 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 study facility.
• Female subjects must fulfill one of the following criteria:
• Postmenopausal women must have had ≥ 12 months of spontaneous amenorrhea with follicle-stimulating hormone concentration consistently ≥40 mIU/mL and must have a negative pregnancy test result at Screening and Check-in.
• 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.
• Must be willing to not engage in sexual intercourse from Check-in until the final follow-up visit on Day 120 (± 5 days).
• Must be willing to use an acceptable method of birth control until the final follow-up visit on Day 120 (± 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 120 (± 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 18.5 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 120 (± 5 days).
• Must agree to abide by study restrictions and be willing to sign an informed consent form (ICF).

Exclusion Criteria

• 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 35 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/pomeg