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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

raxibacumab

Intervention Type DRUG

40 mg/kg intravenously, double dose (day 0 and 14), Group 1

2

Group Type EXPERIMENTAL

raxibacumab

Intervention Type DRUG

40 mg/kg intravenously, single dose, day 0, Group 2

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

40 mg/kg intravenously, double dose (day 0 and 14), Group 3

4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

40 mg/kg placebo, single dose (day 0), Group 4

Interventions

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placebo

40 mg/kg intravenously, double dose (day 0 and 14), Group 3

Intervention Type DRUG

raxibacumab

40 mg/kg intravenously, double dose (day 0 and 14), Group 1

Intervention Type DRUG

placebo

40 mg/kg placebo, single dose (day 0), Group 4

Intervention Type DRUG

raxibacumab

40 mg/kg intravenously, single dose, day 0, Group 2

Intervention Type DRUG

Eligibility Criteria

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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)

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes