Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects
Lead Sponsor:
Human Genome Sciences Inc.
Collaborating Sponsors:
GlaxoSmithKline
Emergent BioSolutions
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and tolerability of raxibacumab in healthy subjects.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT00639678
Start Date
March 1 2008
End Date
September 1 2008
Last Update
November 15 2018
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