Clinical Trial: Ph1 Study of Valortim and Ciprofloxacin in Humans

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: A Phase I, Single Blind, Randomized, Placebo Controlled, Drug Interaction Study of Intravenous (IV) Valortim® and Intravenous (IV) Ciprofloxacin in Healthy, Normal Subjects

Brief Summary: The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human subjects.

Detailed Summary: Valortim (MDX-1303) is a fully human monoclonal antibody (hmAb) with a high affinity for B. anthracis protective antigen (PA). Valortim is designed to target PA, which is one of three plasmid-encoded proteins that together form the toxins released by B. anthracis. Individually, these proteins (protective antigen (PA), lethal factor (LF) and edema factor (EF)) are inactive. Toxic effects require the transport of LF and EF into the host cell, mediated by the activity of PA. Valortim binds to PA and interferes with the activity of the toxins. Based on both non-clinical and clinical data, Valortim may have utility for the pre- and post-exposure prophylaxis of individuals exposed to, or at risk of exposure to, B. anthracis and for the treatment of individuals displaying signs or symptoms of inhalational anthrax. Because the treatment of inhalational anthrax includes the use of antibiotics such as fluoroquinolones, it is necessary to demonstrate that there are no adverse interactions between newer therapeutic interventions and these medications. The purpose of this study is to assess the safety and pharmacokinetics of ciprofloxacin (a commonly used fluoroquinolone for both treatment and post-exposure prophylaxis of anthrax) and Valortim following co-administration, as well as the safety and tolerability of these medications when administered concomitantly. These data are intended to support the use of Valortim as a treatment for inhalational anthrax.
Sponsor: PharmAthene, Inc.

Current Primary Outcome: Determination of changes from baseline for clinical laboratory tests and urinalysis, blood pressure, heart rate, respiratory rate, body temperature, physical examination and ECG [ Time Frame: 134 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluation of PK parameters for IV administration of ciprofloxacin when dosed concomitantly with Valortim [ Time Frame: 134 days ]

Original Secondary Outcome: Same as current

Information By: PharmAthene, Inc.

Dates:
Date Received: August 22, 2009
Date Started: August 2009
Date Completion: July 2010
Last Updated: August 9, 2010
Last Verified: August 2009