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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00639678
First received: March 13, 2008
Last updated: February 13, 2014
Last verified: January 2014
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: placebo
Drug: raxibacumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized to a treatment group at a ratio of 3:1 (raxibacumab:placebo). Participants were randomized to the double dose cohorts first. When randomization was completed for the double-dose cohorts, participants were then randomized into the single-dose cohorts.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 322 participants were randomized and 320 participants were administered at least one dose of study treatment.

Reporting Groups
  Description
Placebo - Single-Dose Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
Placebo - Double-Dose Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
Raxibacumab - Single-Dose Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
Raxibacumab - Double-Dose Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.

Participant Flow:   Overall Study
    Placebo - Single-Dose     Placebo - Double-Dose     Raxibacumab - Single-Dose     Raxibacumab - Double-Dose  
STARTED     74     6     217     23  
COMPLETED     70     5     206     23  
NOT COMPLETED     4     1     11     0  
Withdrawal by Subject                 3                 0                 4                 0  
Lost to Follow-up                 1                 0                 6                 0  
Adverse Event                 0                 1                 0                 0  
Lack of Compliance                 0                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo - Single-Dose Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
Placebo - Double-Dose Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
Raxibacumab - Single-Dose Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
Raxibacumab - Double-Dose Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
Total Total of all reporting groups

Baseline Measures
    Placebo - Single-Dose     Placebo - Double-Dose     Raxibacumab - Single-Dose     Raxibacumab - Double-Dose     Total  
Number of Participants  
[units: participants]
  74     6     217     23     320  
Age  
[units: Years]
Mean ± Standard Deviation
  39.8  ± 16.8     52.2  ± 13.8     40.3  ± 16.3     48.5  ± 14.6     41.0  ± 16.4  
Gender  
[units: Participants]
         
Female     30     4     117     13     164  
Male     44     2     100     10     156  
Race/Ethnicity, Customized  
[units: Participants]
         
White     57     4     143     21     225  
Asian     4     0     15     0     19  
Black or African American     4     2     21     1     28  
Native Hawaiian or Other Pacific Islander     0     0     2     0     2  
Not Listed     0     0     1     0     1  
Multiracial     2     0     7     0     9  
Hispanic or Latino origin     7     0     28     1     36  



  Outcome Measures
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1.  Primary:   Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

2.  Primary:   Number of Participants With Hematological Toxicities of the Indicated Grade   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

3.  Primary:   Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

4.  Primary:   Number of Participants With Liver Toxicities of the Indicated Grade   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

5.  Primary:   Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

6.  Primary:   Number of Participants With Electrolyte Toxicities of the Indicated Grade   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

7.  Primary:   Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

8.  Primary:   Number of Participants With Other Chemistry Toxicities of the Indicated Grade   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

9.  Primary:   Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

10.  Primary:   Number of Participants With Thyroid Toxicities of the Indicated Grade   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

11.  Primary:   Number of Participants With Urinalysis Toxicities of the Indicated Grade   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

12.  Primary:   Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

13.  Primary:   Number of Participants Who Developed an Anti-raxibacumab Antibody Response   [ Time Frame: From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose) ]

14.  Secondary:   Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose   [ Time Frame: 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 ]

15.  Secondary:   Mean Raxibacumab Concentration-time Following Two IV Infusion Doses   [ Time Frame: 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00639678     History of Changes
Other Study ID Numbers: HGS1021-C1063
Study First Received: March 13, 2008
Results First Received: September 5, 2013
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration