Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01265745 |
Recruitment Status
:
Completed
First Posted
: December 23, 2010
Last Update Posted
: December 9, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anthrax | Drug: Normal Saline for Injection Biological: MDX1303 | Phase 1 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265745
United States, Kansas | |
Quintiles Phase I Unit | |
Overland Park, Kansas, United States, 66223 |
Principal Investigator: | Ralph Schutz, MD | Quintiles Phase I Services | |
Study Director: | Valeire D Riddle, MD | Sponsor Medical Monitor |
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 Key Record Dates |
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 |