Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00639678
First received: March 13, 2008
Last updated: October 29, 2012
Last verified: October 2012
History of Changes

March 13, 2008
October 29, 2012
March 2008
July 2008   (final data collection date for primary outcome measure)
Safety assesments (physical exams, adverse event reporting, lab testing / analysis, and immunogenicity testing) [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639678 on ClinicalTrials.gov Archive Site
Pharmacokinetic (PK) analysis (blood testing / analysis) [ Time Frame: entire study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects
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

To evaluate the safety and tolerability of raxibacumab in healthy subjects.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: placebo
    40 mg/kg intravenously, double dose (day 0 and 14), Group 3
  • Drug: raxibacumab
    40 mg/kg intravenously, double dose (day 0 and 14), Group 1
  • Drug: placebo
    40 mg/kg placebo, single dose (day 0), Group 4
  • Drug: raxibacumab
    40 mg/kg intravenously, single dose, day 0, Group 2
  • Experimental: 1
    Intervention: Drug: raxibacumab
  • Experimental: 2
    Intervention: Drug: raxibacumab
  • Placebo Comparator: 3
    Intervention: Drug: placebo
  • Placebo Comparator: 4
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
September 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00639678
HGS1021-C1063
Yes
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Human Genome Sciences Inc., a GSK Company
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP