At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 322 enrolled
Drug / intervention
placebo +3 moredrug
Likely dose
placebo 40 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating placebo and raxibacumab for Healthy. Completed, enrolled 322 participants.
Detailed Summary
To evaluate the safety and tolerability of raxibacumab in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
CollaboratorsGlaxoSmithKline, Emergent BioSolutions
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedMar 2008
Primary CompletionJul 2008
Study CompletionSep 2008
TodayJul 2026
First PostedMar 20, 2008
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.3 years ago
Interventions
placebodrug
40 mg/kg intravenously, double dose (day 0 and 14), Group 3
raxibacumabdrug
40 mg/kg intravenously, double dose (day 0 and 14), Group 1
placebodrug
40 mg/kg placebo, single dose (day 0), Group 4
raxibacumabdrug
40 mg/kg intravenously, single dose, day 0, Group 2