Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects

• Status: Terminated
• Trial end date: 2017-03-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emergent BioSolutions
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Pharmaceutical Solutions

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.