NCT02696291

Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects

Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral solution when administered to healthy subjects three times a day (TID) for 7 days.

Detailed description

This is a phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose study to evaluate the safety and pharmacokinetics of UV-4B oral solution when administered to healthy subjects TID for 7 days. Three cohorts of 8 subjects each (6 active, 2 placebo) are planned and up to 2 additional cohorts may be added pending safety review of the initial cohorts. Safety review will occur after each cohort. Safety is evaluated through Day 15 on the basis of adverse event (AE) monitoring, clinical laboratory testing (hematology, serum chemistry, coagulation, urinalysis), vital signs, physical examinations (PE), electrocardiograms (ECG), and fecal occult blood testing. Blood samples are collected at specified intervals up to Day 10 for pharmacokinetic assessment.

Conditions

• Viral Infection

Interventions

Type	Name	Description
DRUG	UV-4B 30 mg oral solution	UV-4B 30 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days
DRUG	UV-4B 75 mg oral solution	UV-4B 75 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days
DRUG	UV-4B 150 mg oral solution	UV-4B 150 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days
DRUG	UV-4B X mg (dose to be determined) oral solution	UV-4B X mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days
DRUG	UV-4B Y mg (dose to be determined) oral solution	UV-4B Y mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days
DRUG	Placebo	Placebo oral solution administered TID (every 8 ± 0.5 hours) for 7 days

Timeline

• Start date: 2016-05-27
• Primary completion: 2017-03-02
• Completion: 2017-03-02
• First posted: 2016-03-02
• Last updated: 2024-03-18
• Results posted: 2018-03-16

Locations

2 sites across 1 country: United States