NCT02061358

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Viral Infection

Interventions

Type	Name	Description
DRUG	UV-4B 3 mg	Oral solution, single dose
DRUG	UV-4B 10 mg	Oral solution, single dose
DRUG	UV-4B 30 mg	Oral solution, single dose
DRUG	UV-4B 90 mg	Oral solution, single dose
DRUG	UV-4B 180 mg	Oral solution, single dose
DRUG	UV-4B 360 mg	Oral solution, single dose
DRUG	UV-4B 720 mg	Oral solution, single dose
DRUG	UV-4B 1000 mg	Oral solution, single dose
DRUG	Placebo	Oral solution, single dose

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2014-02-12
• Last updated: 2024-03-18
• Results posted: 2016-09-01

Locations

1 site across 1 country: United States