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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT00493220
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18-65 years of age
* If female: non-lactating; non-pregnant; and incapable of becoming pregnant, or taking specific precautions to avoid becoming pregnant before and during study
* Normal clinical laboratory parameters
* Adequate venous access in both upper extremities
* Agreeing to refrain from smoking and from ingesting any alcohol or caffeine-containing products before and during the study
* Good health based on medical history, physical examination and laboratory tests
* Non-smoking; or smoking less than 10 cigarettes per day and willing to refrain from use of nicotine products before and during study
Exclusion Criteria:
* Received a cephalosporin within the 21 days prior to study or anticipated to receive non-study cephalosporin during study
* Pregnant or breast-feeding.
* Previously exposed to a hyaluronidase drug product
* Medical condition presenting unacceptable safety risk or likely to prevent completion of study
* Known hypersensitivity to hyaluronidase or any other ingredient in HYLENEX recombinant
* Contraindication to ceftriaxone, including known allergy to beta-lactam antibiotics
* Local condition precluding subcutaneous injection or injection site evaluation
* History of gastrointestinal disease (in particular colitis)
* Consumption of caffeine- or other methylxanthine-containing beverage within 24 hours before and/or during the PK sampling period
* Participation in study of any investigational drug or device within 30 days before this study
* Serum hemoglobin \<12 g/dL.
* Blood donation or significant loss of blood within 56 days, or plasma donation within 7 days, prior to study
* Medical history/condition, screening physical examination finding or clinical laboratory result precluding safe participation in study, or which might adversely effect interpretation of study results
* History of drug or alcohol abuse within 2 years prior to study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00493220
Study Brief:
Protocol Section:
NCT00493220