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

Phase 1 Completed 30 enrolled Baxter Healthcare Corporation Halozyme Therapeutics · collab

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start: 2007-06
Primary completion: 2007-09
Completion: 2007-09

Publications

Results Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010 Feb;26(2):279-88. doi: 10.1185/03007990903432900.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftriaxone	Other / unclassified	1 g	Subcutaneous
Subject	rHuPH20	Protein / enzyme biologic	150 iu	Subcutaneous

Indications

No indication recorded.