Ph1 Study of Valortim and Ciprofloxacin in Humans

PHASE1SuspendedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

July 31, 2010

Conditions
Anthrax
Interventions
DRUG

Ciprofloxacin and Valortim

Days 1-3 400mg IV Ciprofloxacin BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.

DRUG

Placebo Antibiotic and Valortim

Days 1-3 20mg/kg IV Normal Saline BID over 60 minutes. Day 4 20mg/kg Valortim IV over 60 minutes.

OTHER

Placebo Antibiotic and Placebo Valortim

Days 1-3 200mL IV Normal Saline for Placebo Antibiotic over 60 minutes. Day 4 200mL IV Normal Saline for Placebo Valortim over 60 minutes.

Trial Locations (1)

66211

Quintiles Phase I Services, Overland Park

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Medarex

INDUSTRY

collaborator

Quintiles, Inc.

INDUSTRY

collaborator

Department of Health and Human Services

FED

lead

PharmAthene, Inc.

INDUSTRY