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

Purpose

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

Condition	Intervention	Phase
Allergic Reactions	Biological: Valortim and selected Components Drug: Valortim and Selected Components	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I, Open Label, Controlled Study of Valortim® (MDX-1303) and Its Selected Formulation Components When Introduced Percutaneously in Subjects Who Have and Have Not Been Exposed to Valortim Administered Intravenously

Resource links provided by NLM:

MedlinePlus related topics: Allergy Anthrax

U.S. FDA Resources

Further study details as provided by PharmAthene, Inc.:

Primary Outcome Measures:

Skin Testing Results [ Time Frame: Initial results assessed after 15minutes and up to 72 hours. ] [ Designated as safety issue: Yes ]
Assessment of any wheal reaction from the study drug or its selected components and how this compares to the positive and negative control

Enrollment:	5
Study Start Date:	July 2010
Study Completion Date:	September 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Stage I Three (3) healthy male or female volunteers aged 18-59 years, not previously exposed to Valortim and who do not have pre-existing allergies	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 Other Name: Anthrax
Experimental: Stage II Up to 4 healthy male or female volunteers aged 18-59 previously exposed to intravenous (IV) Valortim in PharmAthene Study #0036-08-05	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 Other Name: Anthrax

Arms

Assigned Interventions

Experimental: Stage I

Three (3) healthy male or female volunteers aged 18-59 years, not previously exposed to Valortim and who do not have pre-existing allergies

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

Other Name: Anthrax

Experimental: Stage II

Up to 4 healthy male or female volunteers aged 18-59 previously exposed to intravenous (IV) Valortim in PharmAthene Study #0036-08-05

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

Other Name: Anthrax

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Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:Stage I Subjects

In the opinion of the Investigator, subjects should be in generally good health, based upon pre-study medical history and abbreviated physical exam.
Female subjects cannot be pregnant, as confirmed by a negative urine pregnancy test at Study Day 1, prior to skin testing.
Women of childbearing potential may be enrolled if one of the following criteria applies:
- Must be using an effective form of contraception for at least one month prior to study entry, must have a negative urine pregnancy test on Day 1, prior to skin testing
- Is sexually abstinent
- Is monogamous with a vasectomized partner (>3 months prior)
- Is postmenopausal (i.e. no cycle for at least the previous 12 months, is of menopausal age (>45 years) and has a negative urine pregnancy test on Day 1, prior to skin testing
- Is surgically sterilized
- Has had a total hysterectomy
Sexually active male subjects may be enrolled if one of the following criteria applies:
- Has had a vasectomy
- Using condoms and whose partner is using an acceptable form of contraception *Is sexually abstinent.
In addition to the Inclusion Criteria above, Stage II Subjects must also meet the following criteria :
- Must have participated in PharmAthene Study #0036-08-05 and have been previously exposed in that study to Valortim.

Exclusion Criteria: Stage I & II

Antihistamine use within 14 days of testing. Medications with antihistamine properties (i.e., anticholinergic agents, phenothiazine), beta-blockers, MAO-inhibitors or tricyclic antidepressant use within 1 day of testing.
Dermatographia, or extreme skin sensitivity.
History of allergic rhinitis, asthma or eczema.
Outward signs of active allergies or upper respiratory infection.
Known pregnancy as confirmed by urine pregnancy testing on Day 1, prior to skin testing procedures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204866

Locations

United States, Kansas
Kansas City Allergy and Asthma
Overland Park, Kansas, United States, 66210

Sponsors and Collaborators

PharmAthene, Inc.

National Institute of Allergy and Infectious Diseases (NIAID)

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Jeffrey Wald, MD	Kansas City Allergy and Asthma
Study Director:	Valerie Riddle, MD	Sponsor Medical Monitor

More Information

No publications provided

Responsible Party:	Pharmathene, Inc., Clinical Project Manager
ClinicalTrials.gov Identifier:	NCT01204866 History of Changes
Other Study ID Numbers:	0036-08-05-A, HHSN272200700033C, 09-0117
Study First Received:	September 16, 2010
Last Updated:	September 23, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by PharmAthene, Inc.:

Allergic-Like Reaction
Selected Formulation Components

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013