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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Human Genome Sciences Inc.; Human Genome Sciences Inc., a GSK Company
• Collaborators: Emergent BioSolutions; GlaxoSmithKline
• Treatments: Antibodies, Monoclonal

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.