Ph1 Study of Valortim and Doxycycline in Humans

PHASE1TerminatedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

October 31, 2009

Study Completion Date

December 31, 2009

Conditions
Anthrax
Interventions
DRUG

Doxycycline and Valortim

Days 1-5 100mg IV Doxycycline BID over 60 minutes. Day 6 20mg/kg Valortim IV over 60 minutes.

DRUG

Placebo Antibiotic and Valortim

Days 1-5 20mg/kg IV Normal Saline BID over 60 minutes. Day 6 20mg/kg IV Valortim over 60 minutes.

DRUG

Placebo Antibiotic and Placebo Valortim

Days 1-5 200mL IV Normal Saline for Placebo Antibiotic BID over 60 minutes. Day 6 20mg/kg 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