Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT01204866
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT01204866
Study Brief:
Protocol Section:
NCT01204866