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

NCT01204866 | Completed Phase 1 DMC

• 3 other identifiers: 0036-08-05-AHHSN272200700033C09-0117
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Allergic-Like Reaction; Selected Formulation Components

Outcome Measures

Primary Outcomes (1)

• Skin Testing Results

  Assessment of any wheal reaction from the study drug or its selected components and how this compares to the positive and negative control

  Initial results assessed after 15minutes and up to 72 hours.

Study Arms (2)

Stage I

EXPERIMENTAL

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

Stage II

EXPERIMENTAL

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

Interventions

Valortim and Selected Components BIOLOGICAL

* 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

Also known as: Anthrax

Stage I

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Must have participated in PharmAthene Study #0036-08-05 and have been previously exposed in that study to Valortim.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmAthene, Inc.: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Kansas City Allergy and Asthma

Overland Park, Kansas, 66210, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Jeffrey Wald, MD

  Kansas City Allergy and Asthma

  PRINCIPAL INVESTIGATOR

• Valerie Riddle, MD

  Sponsor Medical Monitor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 24, 2010

Record last verified: 2010-09

Locations

US (1)