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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PharmAthene, Inc.
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)

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.