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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are:

• to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration;

• and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baxter Healthcare Corporation
• Collaborator: Halozyme Therapeutics
• Treatments: Ceftriaxone

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