Clinical trial NCT00639678: A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: healthy volunteers
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
name: Emergent BioSolutions
First posted: 2008-03-20
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With Hematological Toxicities of the Indicated Grade
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With Liver Toxicities of the Indicated Grade
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With Electrolyte Toxicities of the Indicated Grade
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With Other Chemistry Toxicities of the Indicated Grade
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With Thyroid Toxicities of the Indicated Grade
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With Urinalysis Toxicities of the Indicated Grade
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
measure: Number of Participants Who Developed an Anti-raxibacumab Antibody Response
timeFrame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)
Secondary outcomes:
measure: Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose
timeFrame: Pre-dose on Day 0, at 30 minutes and 2 to 6 hours after completion of raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose
measure: Mean Raxibacumab Concentration-time Following Two IV Infusion Doses
timeFrame: Pre-dose on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Migone TS, Subramanian GM, Zhong J, Healey LM, Corey A, Devalaraja M, Lo L, Ullrich S, Zimmerman J, Chen A, Lewis M, Meister G, Gillum K, Sanford D, Mott J, Bolmer SD. Raxibacumab for the treatment of inhalational anthrax. N Engl J Med. 2009 Jul 9;361(2):135-44. doi: 10.1056/NEJMoa0810603.