NCT00515385

A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults

A Phase 1, Randomized, Double-Blind, Dose-Escalation Cohort Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of MGAWN1, a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus, in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this phase 1, double-blind, cohort study is to evaluate the safety, tolerability, and pharmacokinetics of escalating doses of MGAWN1 administered as a single intravenous (IV) infusion to healthy adults. Subjects will be enrolled sequentially into one of 5 dose-level cohorts, with 8 subjects in each cohort. Six subjects in each cohort will receive MGAWN1 (a Neutralizing, Humanized, Monoclonal Antibody (IgG1k) to West Nile Virus) and 2 will receive a saline control.

Conditions

• West Nile Virus

Interventions

Type	Name	Description
DRUG	MGAWN1	Eight subjects per cohort, each receives a single IV infusion of MGAWN1 of saline control on study day 0 (6 MGAWN1, 2 saline control. Cohort 1 - 0.3 mg/kg Cohort 2 - 1 mg/kg Cohort 3 - 3 mg/kg Cohort 4 - 10 mg/kg Cohort 5 - 30 mg/kg
DRUG	MGAWN1	Single IV dose
OTHER	Placebo	Single IV dose

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2007-08-13
• Last updated: 2022-02-22

Locations

1 site across 1 country: United States