Overview

Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Unither Virology
Collaborators:
Emergent BioSolutions
Quintiles, Inc.
Treatments:
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Healthy subjects

- Women: non-pregnant, non-lactating; if of childbearing potential, on specified
contraception measures during the study period

- Men: using barrier contraception measures during the study period

Exclusion Criteria:

- Health conditions

- Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins,
hormonal birth control)