Status:
COMPLETED
Study of Valortim® (MDX-1303) and Its Selected Formulation Components Percutaneous Use
Lead Sponsor:
PharmAthene, Inc.
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Conditions:
Allergic Reactions
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
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 pre...
Detailed Description
A maximum of 7 subjects will participate in the study. Up to four of these subjects have been previously exposed to IV Valortim. The study will be conducted in two stages. The first stage will be per...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01204866
Start Date
July 1 2010
End Date
September 1 2010
Last Update
September 24 2010
Active Locations (1)
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1
Kansas City Allergy and Asthma
Overland Park, Kansas, United States, 66210