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

Anthrax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202695
• Other study ID #: EBS.AVP.001
• Secondary ID: DMID 09-0008
• Status: Completed
• Phase: Phase 1
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2024
• Source: Emergent BioSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anthrax

Intervention

Drug:
• AVP-21D9
intravenously, single dose
• Placebo
Placebo comparator

Locations

Country	Name	City	State
United States	ICON Development Solutions	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Emergent BioSolutions	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessments	Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 90 or the early withdrawl visit, if applicable.	90 days following infusion
Secondary	Pharmacokinetics (PK) analysis	PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9.	90 days following infusion
Secondary	Immunogenicity analysis	Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation	From day 1 up to day 90 following infusion