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

NCT01265745 | Completed Phase 1 DMC

• 3 other identifiers: 0036-10-01HHSN272200700033CBAA-NIH-NIAID-DMID-07-37
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Anthrax

Keywords

Phase I

Outcome Measures

Primary Outcomes (1)

• Safety

  * 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.

  133 days

Secondary Outcomes (1)

• Pharmacokinetics

  133 days

Study Arms (2)

Valortim

ACTIVE COMPARATOR

Valortim 1mg,5mg,10mg

Biological: MDX1303

Placebo

PLACEBO COMPARATOR

Saline solution will be used as the placebo

Drug: Normal Saline for Injection

Interventions

Normal Saline for Injection DRUG

Equivalent amounts to subjects weight, once over 120 minutes

Placebo

MDX1303 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.

Valortim

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• PharmAthene, Inc.: lead
• Department of Health and Human Services: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Quintiles Phase I Unit

Overland Park, Kansas, 66223, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Saline Solution; Injections

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ralph Schutz, MD

  Quintiles Phase I Services

  PRINCIPAL INVESTIGATOR

• Valeire D Riddle, MD

  Sponsor Medical Monitor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

US (1)