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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Healthy
Interventions
DRUG

SC HYLENEX and Ceftriaxone

single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)

DRUG

SC Placebo and Ceftriaxone

single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes)

DRUG

IV Ceftriaxone

single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Halozyme Therapeutics

INDUSTRY

lead

Baxter Healthcare Corporation

INDUSTRY

NCT00493220 - Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration | Biotech Hunter | Biotech Hunter