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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
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: placebo
Drug: raxibacumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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 GlaxoSmithKline:

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 ]

Enrollment: 322
Study Start Date: March 2008
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: raxibacumab
40 mg/kg intravenously, double dose (day 0 and 14), Group 1
Experimental: 2 Drug: raxibacumab
40 mg/kg intravenously, single dose, day 0, Group 2
Placebo Comparator: 3 Drug: placebo
40 mg/kg intravenously, double dose (day 0 and 14), Group 3
Placebo Comparator: 4 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 Inc., a GSK Company
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00639678     History of Changes
Other Study ID Numbers: HGS1021-C1063
Study First Received: March 13, 2008
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
healthy volunteers

ClinicalTrials.gov processed this record on May 23, 2013