MedTrace Logo

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

NCT02061358 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-03-18

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Unither Virology

    collaborator INDUSTRY

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Thomas Murtaugh, Dr · Senior Medical Research Director, Quintiles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061358 on ClinicalTrials.gov