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

NCT ID: NCT01265745

Last Updated: 2013-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-12-31

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.

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.

Conditions

Anthrax

Keywords

Phase I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Valortim

Valortim 1mg,5mg,10mg

Group Type: ACTIVE_COMPARATOR

MDX1303

Intervention Type: BIOLOGICAL

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

Saline solution will be used as the placebo

Group Type: PLACEBO_COMPARATOR

Normal Saline for Injection

Intervention Type: DRUG

Equivalent amounts to subjects weight, once over 120 minutes

Interventions

Normal Saline for Injection

Equivalent amounts to subjects weight, once over 120 minutes

Intervention Type: DRUG

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.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

PharmAthene, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Schutz, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Phase I Services

Valeire D Riddle, MD

Role: STUDY_DIRECTOR

Sponsor Medical Monitor

Locations

Quintiles Phase I Unit

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

HHSN272200700033C

Identifier Type: OTHER

Identifier Source: secondary_id

BAA-NIH-NIAID-DMID-07-37

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0036-10-01

Identifier Type: -

Identifier Source: org_study_id