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

NCT00639678 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2018-11-15

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

placebo

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

DRUG

raxibacumab

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

DRUG

placebo

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

DRUG

raxibacumab

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Human Genome Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-07-31
Completion
2008-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00639678 on ClinicalTrials.gov