Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration

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