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:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT04350905
Eligibility Criteria:
* INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
-Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 - 45 years
* Live within approximately 15 km of study site
* In good general health as evidenced by medical history
* Willing to allow biological samples to be stored for future research.
* A female is eligible for this study if she meets 1 of the following:
* Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal
ligation or are postmenopausal, as defined by no menses in \>=1 year).
--Of childbearing potential but has negative urine pregnancy test on Day 0
* Agrees to not use scented lotions, deodorants, or topical creams on each feeding day.
* Agrees to not take aspirin or any other NSAID (ex. ibuprofen) within 7 days of a biopsy.
* Agrees to not use oral or topical antihistamines or steroid creams or ointments throughout the
study without prior permission of Principal Investigator (PI).
EXCLUSION CRITERIA:
-Any underlying or current medical condition that, in the opinion of the investigator, would
interfere with participation in the study.
-History of severe allergic reaction (including to mosquito or other insect bites) with generalized
urticaria, angioedema, anaphylaxis, anaphylactoid reaction or any other reaction described by
the participant and deemed severe by the PI.
* Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment
* Self-reported or known history of psychiatric or psychological issues that require treatment and
are deemed by the PI to be a contraindication to protocol participation.
-Any use of medications that affect blood clotting within 3 months or history of abnormal blood
clotting
-History of significant scarring such as keloids after previous biopsies, lacerations, abrasions,
surgeries, or other skin procedures (e.g., cosmetic piercings) that are deemed by the PI to be a
contraindication to protocol participation.
-Pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04350905
Study Brief:
Protocol Section:
NCT04350905