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

NCT02696291 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-03-18

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Timothy Babinchak, MD · Emergent BioSolutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-05-27
Primary Completion
2017-03-02
Completion
2017-03-02

Countries

  • United States

Study Locations

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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 NCT02696291 on ClinicalTrials.gov