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Botulinum Antitoxin Heptavalent

Phase 1

Healthy | Monoclonal antibody | Other |Emergent BioSolutions Inc.|Last Updated: Mar 18, 2024

Target and mechanism

ModalityMonoclonal antibody

Also known as Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Botulinum Antitoxin Heptavalent · 1 trial · 1 indication

Phase 1 1
NCT00360737Safety Study of 7 Botulinum Antitoxin Serotypes Derived From HorsesHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses
Healthy
NCT0036073740
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Study Endpoints

Primary Endpoints

Subjects with adverse events over the course of the study
From Screening Day 1 to Day 28 or early withdrawal

Number of subjects with AEs and severity of AEs up to Day 28

Subjects with serious adverse events over the course of the study
From Screening Day 1 to Day 28 or early withdrawal

Number of subjects with SAEs up to Day 28

Secondary Endpoints

PK analysis for all 7 botulinum antitoxins: AUC0-t
Day Screening 2, Day 0 -30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: AUC0-inf
Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: AUC0-t/AUC0-inf
Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NP-018 - 1 vialEXPERIMENTALSubjects received one vials of NP-018 administered intravenously.
NP-018 - 2 vialsEXPERIMENTALSubjects receive two vials of NP-018 administered intravenously.

Interventions

NameTypeDescription
Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)BIOLOGICALBiological/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). .
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body-mass index of 20 to 30 with minimum body weight of 111 lb (50 kg). * For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including: * Using hormonal contraception (oral or injectable or impla...

Countries:United States
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