Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HYLENEX and Ceftriaxone · 1 trial · 1 indication
Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)
Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)
| Arm | Type | Description |
|---|---|---|
| HYLENEX SC, Placebo SC, IV | EXPERIMENTAL | subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention |
| HYLENEX SC, IV, Placebo SC | EXPERIMENTAL | subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention |
| Placebo SC, HYLENEX SC, IV | EXPERIMENTAL | subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention |
| Placebo SC, IV, HYLENEX SC | EXPERIMENTAL | subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention |
| IV, HYLENEX SC, Placebo SC | EXPERIMENTAL | IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention |
| IV, Placebo SC, HYLENEX SC | EXPERIMENTAL | IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention |
| Name | Type | Description |
|---|---|---|
| SC HYLENEX and Ceftriaxone | DRUG | 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) |
| SC Placebo and Ceftriaxone | DRUG | 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) |
| IV Ceftriaxone | DRUG | single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes) |
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 ext...
HYLENEX and Ceftriaxone is an investigational combination being studied in healthy volunteers. The drug combines HYLENEX recombinant with ceftriaxone for subcutaneous administration. It is currently in Phase 1 clinical development, with the goal of evaluating the pharmacokinetics and safety of this augmented subcutaneous delivery approach.
HYLENEX and Ceftriaxone is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The company is conducting clinical research on this combination product to assess its pharmacokinetic profile and safety in healthy subjects.
HYLENEX and Ceftriaxone is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, which enrolled 30 healthy participants to study the pharmacokinetics and safety of the subcutaneous ceftriaxone administration augmented with HYLENEX recombinant.
HYLENEX and Ceftriaxone has one completed clinical trial registered under NCT00493220, titled 'Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration.' This Phase 1 study enrolled 30 healthy volunteers aged 18 years and older, was randomized, double-blind, and controlled, and has been completed.
HYLENEX and Ceftriaxone combines HYLENEX recombinant with ceftriaxone for subcutaneous administration. HYLENEX recombinant is designed to facilitate the absorption and dispersion of subcutaneously injected fluids and drugs, potentially enhancing the delivery of ceftriaxone, an antibiotic. The combination is being studied to evaluate its pharmacokinetic profile and safety in healthy subjects.