A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects

This study is ongoing, but not recruiting participants.

First Received: March 13, 2008 Last Updated: June 16, 2008 History of Changes

Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00639678

Purpose

To evaluate the safety and tolerability of raxibacumab in healthy subjects.

Condition	Intervention	Phase
Healthy	Drug: placebo Drug: raxibacumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Raxibacumab (Human Monoclonal Antibody to B. Anthracis Protective Antigen) in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Raxibacumab

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

Safety assesments (physical exams, adverse event reporting, lab testing / analysis, and immunogenicity testing) [ Time Frame: entire study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic (PK) analysis (blood testing / analysis) [ Time Frame: entire study ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: raxibacumab 40 mg/kg intravenously, double dose (day 0 and 14), Group 1
2: Experimental	Drug: raxibacumab 40 mg/kg intravenously, single dose, day 0, Group 2
3: Placebo Comparator	Drug: placebo 40 mg/kg intravenously, double dose (day 0 and 14), Group 3
4: Placebo Comparator	Drug: placebo 40 mg/kg placebo, single dose (day 0), Group 4

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Key Inclusion Criteria:

Male or female, 18 years of age or older
Normal laboratory (blood test) results
Subjects are eligible to enter the study if they are not pregnant or nursing, are sterile or of non-childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study (about 2 months)

Key Exclusion Criteria:

History of significant, acute or chronic diseases (ie, heart, lung, gastrointestinal, liver, kidney, neurological or infectious diseases).
Prior immunization with anthrax vaccine adsorbed (AVA), prior treatment with investigational anthrax therapies, prior treatment for anthrax exposure, or prior anthrax infection.
History of Type I hypersensitivity reaction to food or drugs, IV contrast agents, antihistamines, or history of hives.
A current drug or alcohol addiction.
Positive for human immunodeficiency virus (HIV-1), Hepatitis B surface antigen, or Hepatitis C antibody.
Cancer within the last 5 years (with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix).
Participation within 60 days of intiating study or refusal to refrain from participation during the study in any other clinical trials of an investigational compound.
Previous exposure to raxibacumab.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639678

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Director:

Letha Healey, MD

Human Genome Sciences

More Information

No publications provided by Human Genome Sciences

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Migone TS, Subramanian GM, Zhong J, Healey LM, Corey A, Devalaraja M, Lo L, Ullrich S, Zimmerman J, Chen A, Lewis M, Meister G, Gillum K, Sanford D, Mott J, Bolmer SD. Raxibacumab for the treatment of inhalational anthrax. N Engl J Med. 2009 Jul 9;361(2):135-44.

Responsible Party:	Human Genome Sciences, Inc ( Letha Healey, MD )
Study ID Numbers:	HGS1021-C1063
Study First Received:	March 13, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00639678 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Human Genome Sciences:

healthy volunteers

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Healthy
Immunoglobulins

ClinicalTrials.gov processed this record on September 10, 2009