Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | September 2015 |
Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single-Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
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.
UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption
and elimination following a single dose of UV-4B in healthy subjects.
The causative agent of dengue fever is Dengue Virus (DENV), a member of the flavivirus
genus. There are four DENV serotypes. Infection with one serotype results in lifelong
immunity against that serotype, but only limited short-term cross-protection from infection
with the other serotypes. Immunity to one serotype has a downside as subsequent infections
by other serotypes increase the risk of developing more severe forms of dengue, which
includes the most lethal form of the disease, dengue hemorrhagic fever. Traditional
epidemiologic and serologic-based estimates suggest a range of 50 to 100 million DENV
infections per year distributed over 100 countries. Recent cartographic-based modeling
studies suggest that up to 390 million of dengue infections per year, of which 96 million
are associated with clinical symptoms.
genus. There are four DENV serotypes. Infection with one serotype results in lifelong
immunity against that serotype, but only limited short-term cross-protection from infection
with the other serotypes. Immunity to one serotype has a downside as subsequent infections
by other serotypes increase the risk of developing more severe forms of dengue, which
includes the most lethal form of the disease, dengue hemorrhagic fever. Traditional
epidemiologic and serologic-based estimates suggest a range of 50 to 100 million DENV
infections per year distributed over 100 countries. Recent cartographic-based modeling
studies suggest that up to 390 million of dengue infections per year, of which 96 million
are associated with clinical symptoms.
Inclusion Criteria:
- Healthy Subjects
- Non-child bearing potential
Exclusion Criteria:
- Health conditions
- Taking other prescription and non-prescription dugs
We found this trial at
1
site
Click here to add this to my saved trials
