Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Valortim is the name of the experimental drug that volunteers will receive in this study. Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made immune system molecule) for the treatment of inhalation anthrax (when the infection starts in the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the toxin from doing damage to cells. This study is being conducted to see if Valortim given over 120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase, Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the time when you receive the study medication), Follow-up Phase (the time after you receive the study medication) and Final Visit.

Condition or disease	Intervention/treatment	Phase
Anthrax	Drug: Normal Saline for Injection; Biological: MDX1303	Phase 1

Detailed Description:

Twenty-eight subjects will be recruited and entered into one of three dose groups 1mg/kg, 5mg/kg, 10mg/kg or placebo. Subjects will be stagger dosed into one of the three groups and randomly assigned to receive Valortim or saline. Subjects will reside in the clinical trial Phase I Unit from Day -1 through Day 2. After discharge on Day 2, all subjects will return to the Phase I unit 7 times at specified time points over an additional 130 days post-dosing (133 days total participation from check-in on Day -1)or placebo.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase I, Double-blind, Randomized, Placebo Controlled, Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) as a 120 Minute Infusion in Healthy, Normal Subjects
Study Start Date :	December 2010
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Valortim; Valortim 1mg,5mg,10mg	Biological: MDX1303; a sterile solution at a protein concentration of 25 mg/mL: 20 mM sodium citrate, 50 mM sodium chloride, 3.0% mannitol, 50 µM diethylenetriamine pentacetic acid and 0.06% polysorbate 80 at pH 6.5. A tubular, clear glass vial, filled with a 5 mL dose of colorless to pale yellow solution. The vial is sealed with a 20 mm stopper and white flip-off seal.
Placebo Comparator: Placebo; Saline solution will be used as the placebo	Drug: Normal Saline for Injection; Equivalent amounts to subjects weight, once over 120 minutes

Outcome Measures

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Primary Outcome Measures :

1. Safety [ Time Frame: 133 days ]
   • Determination of changes from baseline for clinical laboratory tests and urinalysis, body temperature, heart rate, blood pressure, respiratory rate, physical examination and electrocardiogram (ECG).
   • Occurrence and evaluation of adverse events and serious adverse events.

Secondary Outcome Measures :

1. Pharmacokinetics [ Time Frame: 133 days ]
   Evaluation of the pharmacokinetics/pharmacodynamics of Valortim in healthy human volunteers

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1.Subject must have read, understood, and provided written informed consent 2.Subjects should be in generally good health, based upon pre-study medical history, physical examination, laboratory testing and ECG 3.Laboratory screening values (i.e., hematology, clinical chemistries and urinalysis tests) must be within study-defined ranges 4.No detectable antibody to B. anthracis Protective Antigen (PA-IgG) as measured by ELISA testing at study Screening 5.Women of childbearing potential and sexually active males may be enrolled if protocol specific contraceptives or practices are met 6.Agreement to not receive any vaccinations Day -1 through to 29 days post dosing. Vaccination against B. anthracis is prohibited during the study.8.Body Mass Index (BMI) ≥ 19 and ≤ 30. 9. Abstinence from alcohol for 24 hours prior to study drug

Exclusion Criteria:

1. Prior known or suspected exposure to B. anthracis 2. Prior vaccination for B. anthracis 3.Prior exposure to Valortim as part of a previous clinical trial 4.Immunoglobulin E (IgE) level at screening that is above the upper limit of normal per the laboratory's reference range 5. 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 6. Outward signs of active allergies or upper respiratory infection 7. History of dizziness or fainting upon standing (orthostatic hypotension) which, in the opinion of the Investigator, may interfere with safety evaluations 8. Positive drug result and/or positive alcohol result at time of study Screening or at Day -1

Contacts and Locations

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Locations

United States, Kansas
Quintiles Phase I Unit
Overland Park, Kansas, United States, 66223

Sponsors and Collaborators

PharmAthene, Inc.

Department of Health and Human Services

National Institute of Allergy and Infectious Diseases (NIAID)

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Ralph Schutz, MD	Quintiles Phase I Services
Study Director:	Valeire D Riddle, MD	Sponsor Medical Monitor

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	PharmAthene, Inc.
ClinicalTrials.gov Identifier:	NCT01265745 History of Changes
Other Study ID Numbers:	0036-10-01; HHSN272200700033C ( Other Identifier: HHSN ); BAA-NIH-NIAID-DMID-07-37 ( Other Grant/Funding Number: BAA-NIH-NIAID-DMID-07-37 )
First Posted:	December 23, 2010
Last Update Posted:	December 9, 2013
Last Verified:	December 2013

Keywords provided by PharmAthene, Inc.:

Phase I

Additional relevant MeSH terms:

Anthrax; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections