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

Phase 1CompletedNCT01202695

Emergent BioSolutions50 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anthrax

Interventions

AVP-21D9DRUG

intravenously, single dose

PlaceboDRUG

Placebo comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ICON Development Solutions

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 90 days following infusion

Secondary Outcomes

Pharmacokinetics (PK) analysis

PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9.

Time frame: 90 days following infusion

Immunogenicity analysis

Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation

Time frame: From day 1 up to day 90 following infusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.