Tolerability and Pharmacokinetic Properties of Ondansetron Administered Subcutaneously With Recombinant Human Hyaluronidase in Minipigs and Healthy Volunteers

2014 ◽  
Vol 36 (2) ◽  
pp. 211-224 ◽  
Author(s):  
Samuel S. Dychter ◽  
Rena Harrigan ◽  
Jesse D. Bahn ◽  
Marie A. Printz ◽  
Barry J. Sugarman ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Pharmacokinetic Properties ◽  
Recombinant Human Hyaluronidase

scholarly journals Safety, Tolerability, and Pharmacokinetic Properties of Intravenous Delafloxacin After Single and Multiple Doses in Healthy Volunteers

2016 ◽  
Vol 38 (1) ◽  
pp. 53-65 ◽  
Author(s):  
Randall Hoover ◽  
Thomas Hunt ◽  
Michael Benedict ◽  
Susan K. Paulson ◽  
Laura Lawrence ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Single And Multiple Doses ◽  
Multiple Doses ◽  
Pharmacokinetic Properties

scholarly journals A First-in-Human Study To Assess the Safety and Pharmacokinetics of Monoclonal Antibodies against Human Cytomegalovirus in Healthy Volunteers

2016 ◽  
Vol 60 (5) ◽  
pp. 2881-2887 ◽  
Author(s):  
Kiran Dole ◽  
Florencia Pereyra Segal ◽  
Adam Feire ◽  
Baldur Magnusson ◽  
Juan C. Rondon ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Healthy Volunteers ◽  
Human Cytomegalovirus ◽  
Treatment Options ◽  
Human Study ◽  
Pharmacokinetic Parameters ◽  
Apparent Relationship ◽  
Pharmacokinetic Properties ◽  
Human Igg1 ◽  
The Individual

ABSTRACTHuman cytomegalovirus (HCMV) can cause significant disease in immunocompromised patients and treatment options are limited by toxicities. CSJ148 is a combination of two anti-HCMV human monoclonal antibodies (LJP538 and LJP539) that bind to and inhibit the function of viral HCMV glycoprotein B (gB) and the pentameric complex, consisting of glycoproteins gH, gL, UL128, UL130, and UL131. Here, we evaluated the safety, tolerability, and pharmacokinetics of a single intravenous dose of LJP538 or LJP539 or their combination in healthy volunteers. Adverse events and laboratory abnormalities occurred sporadically with similar incidence between antibody and placebo groups and without any apparent relationship to dose. No subject who received antibody developed a hypersensitivity, infusion-related reaction or anti-drug antibodies. After intravenous administration, both LJP538 and LJP539 demonstrated typical human IgG1 pharmacokinetic properties, with slow clearances, limited volumes of distribution, and long terminal half-lives. The pharmacokinetic parameters were linear and dose proportional for both antibodies across the 50-fold range of doses evaluated in the study. There was no apparent impact on pharmacokinetics when the antibodies were administered alone or in combination. CSJ148 and the individual monoclonal antibodies were safe and well tolerated, with pharmacokinetics as expected for human immunoglobulin.

A Study of the Pharmacokinetic Properties and the In Vivo Kinetics of Erythrocytes Loaded With Dexamethasone Sodium Phosphate in Healthy Volunteers

2018 ◽  
Vol 32 (2) ◽  
pp. 102-110 ◽  
Author(s):  
Shodeinde A. Coker ◽  
Zbigniew M. Szczepiorkowski ◽  
Alan H. Siegel ◽  
Antonio Ferrari ◽  
Giovanni Mambrini ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Sodium Phosphate ◽  
Dexamethasone Sodium Phosphate ◽  
Pharmacokinetic Properties ◽  
In Vivo Kinetics ◽  
Kinetics Of
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