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

Human Genome Sciences

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: placebo; Drug: raxibacumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00639678

HGS1021-C1063

Details and patient eligibility

About

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

Enrollment: 322 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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322 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: raxibacumab

Drug: raxibacumab

2

Experimental group

Treatment:

Drug: raxibacumab

Drug: raxibacumab

3

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

4

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo