NCT01202695

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

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

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

Conditions

• Anthrax

Interventions

Type	Name	Description
DRUG	AVP-21D9	intravenously, single dose
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-09-16
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States