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SUSPENDEDPHASE1

Ph1 Study of Valortim and Ciprofloxacin in Humans

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

NCT00964561•PharmAthene, Inc.

View on ClinicalTrials.gov

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 Description

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.

Eligibility

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy Normal male or female subjects 18 to 59 years of age on Day -1 of the study
•2. Subject must have read, understood, and provided written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures
•3. In the opinion of the Investigator, subjects should be in generally good health, based upon prestudy medical history, physical examination, ECG and laboratory tests
•4. Laboratory screening values (i.e., hematology, clinical chemistries and urinalysis tests) must be within study-defined ranges
•5. No detectable antibody to B. anthracis Protective Antigen (PA-IgG) as measured by ELISA testing at study Screening
•6. Women of childbearing potential may be enrolled if one of the following criteria applies:
•1. Must be using an effective form of contraception (e.g., oral contraceptives, vaginal ring, IUD, injected or implanted hormonal contraception, double barrier method of condom and spermicide, diaphragm with spermicide or sponge with spermicide) for at least one month prior to study entry, must have maintained a normal menstrual pattern for the three months prior to study entry and have a negative pregnancy test at the time of admission to the unit. Women must be willing to continue this contraception throughout the course of the study.
•2. Is sexually abstinent
•3. Is monogamous with a vasectomized partner (\> 3 months prior)
•4. Is postmenopausal (i.e., no cycle for at least the previous 12 months, is of menopausal age (\> 45 years) and has a negative urine pregnancy test prior to enrollment into the study and a negative serum pregnancy test on Day -1)
+11 more criteria

Exclusion Criteria

•1. Prior known or suspected exposure to B. anthracis
•2. Prior vaccination for B. anthracis
•3. Any participants in the original FTIH study of Valortim.
•4. History of drug or alcohol abuse i.e. having been treated either in an in-patient or out-patient facility within 12 months of study Screening
•5. Positive drug result and/or positive alcohol result at time of study Screening or at Day -1
•6. Smoke more than 10 cigarettes per day for the last 6 months
•7. Treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) of study Screening
•8. Use of systemic immunosuppressive agents within 12 months of study Screening. Individuals who have received prednisone or its equivalent in doses of less than 20 mg/day for 14 days or less, as long as it occurred more than 1 month prior to them entering the study and as long as there is no clinical or laboratory evidence of immunosuppression, may be considered for enrollment
•9. Use of NSAIDs within 24 hours prior to dosing
•10. History of asthma requiring any use of inhaled or oral medication within the previous 5 years
+13 more criteria

Locations (1)

Quintiles Phase I Services

Overland Park, Kansas, United States

Key Dates

Start Date

August 1, 2009

Primary Completion Date

February 1, 2010

Completion Date

July 1, 2010

Last Updated

August 10, 2010

Enrollment

ESTIMATED participants

Conditions

Anthrax

Interventions

Ciprofloxacin and Valortim

DRUG

Placebo Antibiotic and Valortim

DRUG

Placebo Antibiotic and Placebo Valortim

OTHER

Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients

NCT00050310

AnthraxBacillus Infections

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NOT_YET_RECRUITING

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

NCT03569514

Anthrax

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 10, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ph1 Study of Valortim and Ciprofloxacin in Humans

Inclusion Criteria

Exclusion Criteria

Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients

Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax

Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.

Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System

An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis

Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers