First Time in Human Study of Protexia

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of Protexia, an experimental drug being developed to protect soldiers against the effects of nerve agents.

Volunteers will be entered into one of five groups. Four of the groups will receive a single intramuscular dose of Protexia or saline placebo on Study Day 1 and will participate in the study for approximately 71 days. One of the groups will receive two intramuscular doses of Protexia or saline placebo - one dose on Study Day 1 and the second dose on Study Day 72. This group will participate in the study for approximately 142 days.

All volunteers will remain at the study site as an inpatient for three days after they are dosed and will be monitored closely by the study doctors and staff. After that, volunteers will return to the study site as outpatients at predetermined intervals. Groups 1, 2, 4, 5 will have a total of 6 follow-up visits and Group 3 will have a total of 12 follow-up visits.

It is expected that this study will provide important information on the safety and tolerabiity of Protexia at one and two doses.

Conditions

• Intervention for Nerve Agent Exposure

Interventions

BIOLOGICAL

Protexia

Single 50 mg IM dose

BIOLOGICAL

Protexia

Single 100 mg dose

BIOLOGICAL

Protexia

Two 250 mg doses, IM, one at Day 1 and one at Day 72

BIOLOGICAL

Protexia

Single 500 mg dose, IM

BIOLOGICAL

Protexia

Single 750 mg dose, IM

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Quintiles, Inc.

  collaborator INDUSTRY

• QPS Holdings LLC

  collaborator INDUSTRY

• PharmAthene, Inc.

  lead INDUSTRY

Principal Investigators

• Ralph A Schutz, MD · Quintiles, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2009-07-31

Completion

2009-11-30

Countries

• United States

Study Locations