At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
UV-4B 3 mg +8 moredrug
Likely dose
UV-4B 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating UV-4B 3 mg, UV-4B 10 mg, and 7 other interventions for Viral Infection. Completed, enrolled 64 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsViral Infection
CountriesUnited States
CollaboratorsQuintiles, Inc., Unither Virology
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartJul 2014
Primary CompletionJul 2015
Study CompletionSep 2015
TodayJul 2026
First PostedFeb 12, 2014
Enrollment StartJul 1, 2014
Primary CompletionJul 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.4 years ago
Interventions
UV-4B 3 mgdrug
Oral solution, single dose
UV-4B 10 mgdrug
Oral solution, single dose
UV-4B 30 mgdrug
Oral solution, single dose
UV-4B 90 mgdrug
Oral solution, single dose
UV-4B 180 mgdrug
Oral solution, single dose
UV-4B 360 mgdrug
Oral solution, single dose
UV-4B 720 mgdrug
Oral solution, single dose
UV-4B 1000 mgdrug
Oral solution, single dose
Placebodrug
Oral solution, single dose