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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
PharmAthene, Inc.
ClinicalTrials.gov Identifier:
NCT01204866
First received: September 16, 2010
Last updated: September 23, 2010
Last verified: September 2010
  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:


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

  Show Detailed Description

  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.
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 April 16, 2014