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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT01116102
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18 to 60 years, inclusive.
* Body mass index 19.0 to 35.0 kg/m2
* Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion
* Free from any clinically significant abnormality on the basis of medical/medication history or physical examination
* Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant
* Negative urine drug and alcohol screens.
Exclusion Criteria:
* Upper back pathology that could interfere with study outcome.
* History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.
* Rales on lung auscultation.
* Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
* Treatment with furosemide, benzodiazepines, or phenytoin.
* Pregnancy or breastfeeding.
* Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study.
* Any other reason which, in the investigator's opinion, would prevent the safe participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01116102
Study Brief:
Protocol Section:
NCT01116102