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Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)

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Contents

clinicaltrials.gov/study/NCT01202695
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT012026950
Health Conditions in Trial
Anthrax
Anthrax
0
Trial Recruitment Size
500
Trial Sponsor
Emergent BioSolutions
Emergent BioSolutions
0
Clinical Trial Start Date
2010
0
Primary Completion Date
2011
0
Study Completion Date
2011
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 10
Official Name
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers0
Last Updated
November 22, 2012
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Care Provider0
Participant0

Other attributes

Intervention Treatment
AVP-21D90
Placebo0
Study summary

Primary: • To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: * To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 * To evaluate the immunogenicity of AVP-21D9

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