Conditions: Viral Infection
Keywords: Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral RNA Virus Infections Virus Diseases Pharmaceutical Solutions Pharmacologic Actions Therapeutic Uses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Subjects receiving UV-4B 3 mg oral solution or placebo arm 2: Subjects receiving UV-4B 10 mg oral solution or placebo arm 3: Subjects receiving UV-4B 30 mg oral solution or placebo arm 4: Subjects receiving UV-4B 90 mg oral solution or placebo arm 5: Subjects receiving UV-4B 180 mg oral solution or placebo arm 6: Subjects receiving UV-4B 360 mg oral solution or placebo arm 7: Subjects receiving UV-4B 720 mg oral solution or placebo arm 8: Subjects receiving UV-4B 1000 mg oral solution or placebo

Interventions: intervention 1: UV-4B 3 mg intervention 2: UV-4B 10 mg intervention 3: UV-4B 30 mg intervention 4: UV-4B 90 mg intervention 5: UV-4B 180 mg intervention 6: UV-4B 360 mg intervention 7: UV-4B 720 mg intervention 8: UV-4B 1000 mg intervention 9: Placebo
Intervention descriptions: intervention 1: Oral solution, single dose intervention 2: Oral solution, single dose intervention 3: Oral solution, single dose intervention 4: Oral solution, single dose intervention 5: Oral solution, single dose intervention 6: Oral solution, single dose intervention 7: Oral solution, single dose intervention 8: Oral solution, single dose intervention 9: Oral solution, single dose

Protocol document: