Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects
Condition: Viral Infection
MeSH terms: Infections; Virus Diseases
Intervention: UV-4B 30 mg oral solution; UV-4B 75 mg oral solution; UV-4B 150 mg oral solution; UV-4B X mg (dose to be determined) oral solution; UV-4B Y mg (dose to be determined) oral solution; Placebo
Intervention description: UV-4B 30 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days; UV-4B 75 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days; UV-4B 150 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days; UV-4B X mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days; UV-4B Y mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days; Placebo oral solution administered TID (every 8 ± 0.5 hours) for 7 days
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Arbovirus Infections; Flaviviridae Infections; Flavivirus Infections; Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Pharmaceutical Solutions; Pharmacologic Actions; Therapeutic Uses

Summary:

      The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral
      solution when administered to healthy subjects three times a day (TID) for 7 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nonsmoking, healthy male or female subject aged 18 to 45 years, inclusive.

          -  Female subject is not pregnant and not lactating.

          -  (Female subjects only who are not postmenopausal or sterile) agreement to use hormonal
             contraception OR intrauterine device PLUS barrier contraception (condom or occlusive
             cap such as a diaphragm or surgical vault cap) AND spermicidal
             foam/gel/cream/suppository starting at least 14 days before the first dose and
             continuing for at least 3 months after the last dose.

          -  (Male subjects only) agreement to use barrier contraception during sexual intercourse
             and to also refrain from sperm donation from the first day of dosing until 3 months
             after the last dose of the study product.

          -  Body weight within 60 to 90 kg, inclusive, and body mass index between 18 to 32 kg/m²,
             inclusive.

          -  Agreement to avoid strenuous exercise starting 4 days before the start of dosing
             through the period of confinement in the clinical unit and for at least 96 hours
             before the follow-up visits.

        Exclusion Criteria:

          -  History of allergy to drugs in the iminosugar class.

          -  Treatment with any investigational products or therapies within 30 days (or 5
             half-lives, whichever is greater) before the first day of dosing.

          -  Current or past history of disease/dysfunction of the pulmonary, cardiovascular,
             endocrine, hematologic, neurological, immune, gastrointestinal genitourinary, or other
             body system.

          -  Abnormalities on physical examination suggestive of conditions that may pose an
             increased risk to the subject; abnormal electrocardiogram results (excluding benign
             conditions); and Grade 1 or higher abnormalities in vital signs at screening and Grade
             2 or higher abnormalities in vital signs at check-in based on a modified version of
             the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in
             Preventive Vaccine Clinical Trials.

          -  Clinical laboratory tests outside the normal range at screening and Grade 2 or higher
             at check-in to the clinical unit.

          -  Creatinine clearance < 90 mL/min (based on Cockcroft-Gault equation).

          -  Proteinuria greater than or equal to 1+.

          -  Any known or expected risk of bleeding.

          -  Scheduled surgical procedure during study participation.

          -  History of alcohol and/or drug abuse within 1 year prior to dosing and/or a positive
             urine drug screen for substances of abuse at screening or check-in. Urine alcohol
             above 50 mg/dL.

          -  Plasma or blood donation within 30 days before the first day of dosing or intention to
             donate within 30 days after the final day of dosing.

          -  Treatment with any medication, either prescription or nonprescription, including
             dietary supplements or herbal medications, within 14 days before dosing (within 30
             days before dosing for hepatic or renal clearance-altering agents) and is unable to
             refrain from any medication during the study period. Exceptions are acetaminophen (not
             more than 2 g/day), vitamin products at recommended daily doses or hormonal birth
             control.

          -  Positive serology test for HIV antibodies, hepatitis B surface antigen, or hepatitis C
             virus antibody at screening.

          -  History of relevant food allergies (ie, eggs or other components of standard clinic
             meals) or unwilling to comply with diet restrictions.

          -  Psychological and/or emotional problems which would render the informed consent
             invalid, or limit the ability of the subject to comply with the study requirements;

          -  Concurrent enrollment in any other clinical trial within 30 days.