CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)biological
Likely dose
Not stated in 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.

Search/NCT00360737
NCT00360737Phase 1Completed
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Pharmacokinetics of a Heptavalent Equine-derived Botulinum Antitoxin (NP-018)

Emergent BioSolutions·interventional·Posted Aug 7, 2006·Updated Mar 18, 2024

In Brief

A Phase 1 clinical trial evaluating Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) for Healthy. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The primary purpose of the study is to evaluate the safety of the 7 Botulinum Antitoxin Serotypes derived from horses using various laboratory measurements, clinical examinations and adverse events. In addition, following intravenous (injected into the vein) administration assessing how much 7 Botulinum Antitoxin remains in the body.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsDepartment of Health and Human Services

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2006
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2006
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 19.9 years ago

Interventions

Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)biological

Biological/Vaccine NP-018 (heptavalent equine-derived botulinum antitoxin) is prepared from pooled plasma obtained from horses that have been immunized against one of seven botulinum antitoxins (A-G). .