Study of Valortim® (MDX-1303) and Its Selected Formulation Components Percutaneous Use

Summary

The purpose of this study is to determine if Valortim, or one or more of its selected formulation components, induces a wheal reaction when introduced percutaneously.

Two of 4 subjects dosed in a previous study with a modified formulation of Valortim experienced treatment related adverse events which were suggestive of allergic or allergic-like reactions. In order to better characterize these reactions and determine if they represent allergic or allergic-like reactions to Valortim or one or more of its components, skin testing of Valortim and selected components on naïve and Valortim-exposed subjects will be performed in this study

Conditions

• Allergic Reactions

Interventions

BIOLOGICAL

Valortim and selected Components

* Valortim (Lot #10-08-001, 25 mg/mL) will be filtered through a 0.22 µm syringe filter and diluted 1:1000, 1:100, 1:10, and 1:1 in saline. * Polysorbate 80 will be diluted in saline to the following concentrations: 0.06 mg/mL, 0.2 mg/mL, and 0.6 mg/mL. * Mannitol (30 mg/mL) will be diluted in saline to the following concentrations: 1:1000, 1:100, 1:10, and 1:1 * Histamine (1 mg/mL), positive control * Saline (0.9%), negative control

DRUG

Valortim and Selected Components

• It is anticipated that up to 4 subjects that received Valortim in a previous study (#0036-08-05) will participate in Stage II of the study; two of these subjects experienced adverse events while being dosed with Valortim. Subjects will each be tested percutaneously with Valortim, polysorbate 80, mannitol, histamine, and saline. * Only one subject will be skin tested in a single day. * The appropriate dilution for Valortim, mannitol, and polysorbate 80 will be based on the results from Stage I of this study. As was done in Stage I, Valortim will be filtered through a 0.22 µm syringe filter. Histamine (1 mg/mL) and saline (0.9%) will be used as the positive and negative controls, respectively

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• PharmAthene, Inc.

  lead INDUSTRY

Principal Investigators

• Jeffrey Wald, MD · Kansas City Allergy and Asthma

• Valerie Riddle, MD · Sponsor Medical Monitor

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2010-08-31

Completion

2010-09-30

Countries

• United States

Study Locations