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

PHASE1TerminatedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

May 27, 2016

Primary Completion Date

March 2, 2017

Study Completion Date

March 2, 2017

Conditions
Viral Infection
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

Trial Locations (2)

53704

Clinical Research Unit, Madison

75247

Clinical Research Unit, Dallas

Sponsors
All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Emergent BioSolutions

INDUSTRY