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

Emergent BioSolutions

Status and phase: Completed; Phase 1

Conditions: Anthrax

Treatments: Drug: AVP-21D9; Drug: Placebo

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01202695

DMID 09-0008 (Other Grant/Funding Number)

EBS.AVP.001

Details and patient eligibility

About

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

Full description

This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Healthy volunteers, between 18 and 45 years of age
• Normal laboratory (blood test) results

Key Exclusion Criteria:

• Prior immunization with anthrax vaccine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

AVP-21D9

Experimental group

Treatment:

Drug: AVP-21D9

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo