Pharmacokinetics and safety profile of the human anti-Pseudomonas aeruginosa serotype O11 immunoglobulin M monoclonal antibody KBPA-101 in healthy volunteers

Antimicrobial Agents and Chemotherapy

Volumn 53, Issue 8, 2009, Pages 3442-3446

  Lazar, Hedvika ^a   Horn, Michael P ^a,d   Zuercher, Adrian W ^a,e   Imboden, Martin A ^a,f   Durrer, Peter ^b   Seiberling, Michael ^c   Pokorny, Rolf ^c   Hammer, Christophe ^a   Lang, Alois B ^a,g  

^a Kenta Biotech   (Switzerland)

^b Berna Biotech AG   (Switzerland)

^c Swiss Pharma Contract   (Switzerland)

^d UNIVERSITY OF BERN   (Switzerland)

^e NESTLÉ RESEARCH CENTER   (Switzerland)

^f ZLB Behring AG   (Switzerland)

^g GENEURO SA   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY KBPA 101; PLACEBO; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; COMMON COLD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEART VENTRICLE PRESSURE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; MALE; MAXIMUM PLASMA CONCENTRATION; MYALGIA; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SEROTYPE; SIDE EFFECT; SORE THROAT; TENSION HEADACHE; UNSPECIFIED SIDE EFFECT;

ADULT; ANTI-BACTERIAL AGENTS; ANTIBODIES, MONOCLONAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOGLOBULIN M; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; PSEUDOMONAS AERUGINOSA;

EID: 67749124368     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01699-08     Document Type: Article

References (19)

1. Bender, N. K., C. E. Heilig, B. Dröll, J. Wohlgemuth, F. P. Armbruster, and B. Heilig. 2007. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatol. Int. 27:269-274.
2. Buret, A., and A. W. Cripps. 1992. The immunoevasive activities of Pseudomonas aeruginosa. Relevance for cystic fibrosis. Am. Rev. Respir. Dis. 148: 793-805.
3. Burgess, D. S. 2005. Use of pharmacokinetics and pharmacodynamics to optimize antimicrobial treatment of Pseudomonas aeruginosa infections. Clin. Infect. Dis. 40(Suppl. 2):S99-S104.
4. Daifuku, R., E. A. Panacek, K. Haenftling, W. K. Swenson, A. W. Prescott, and J. L. Johnson. 1993. Pilot study of anti-lipopolysaccharide human monoclonal antibody MAB-T88 in patients with gram-negative sepsis. Hum. Antibodies Hybridomas 4:36-39.
5. De Groot, A. S., and D. W. Scott. 2007. Immunogenicity of protein therapeutics. Trends Immunol. 28:482-490.
6. Eggimann, P., and D. Pittet. 2001. Infection control in the ICU. Chest 120:2059-2093.
7. Gales, A. C., R. N. Jones, J. Turnidge, R. Rennie, and R. Ramphal. 2001. Characterization of Pseudomonas aeruginosa isolates: occurrence rates, antimicrobial susceptibility patterns, and molecular typing in the global SENTRY Antimicrobial Surveillance Program, 1997-1999. Clin. Infect. Dis. 32(Suppl. 2):S146-S155.
8. Gibaldi, M., and F. Perrier. 1982. Pharmacokinetics, p. 412-413. In Drugs and the pharmaceutical sciences, 2nd ed., vol. 15. Marcel Dekker Inc. Press, New York, NY.
9. Harrison, F. J. J., D. Rohm, T. Kohzuki, and H. Noguchi. 1997. Pharmacokinetics, tolerability, and preliminary efficacy of human anti-Pseudomonas aeruginosa monoclonal antibodies in pneumonia and burn infection patients. Hybridoma 16:413-420.
10. Lang, A. B., A. Rudeberg, M. H. Schoni, J. U. Que, E. Furer, and U. B. Schaad. 2004. Vaccination of cystic fibrosis patients against Pseudomonas aeruginosa reduces the proportion of patients infected and delays time to infection. Pediatr. Infect. Dis. J. 23:504-510.
11. Lang, A. B., U. B. Schaad, A. Rudeberg, J. Wedgwood, J. U. Que, E. Furer, and S. J. Cryz, Jr. 1995. Effect of high-affinity anti-Pseudomonas aeruginosa lipopolysaccharide antibodies induced by immunization on the rate of Pseudomonas aeruginosa infection in patients with cystic fibrosis. J. Pediatr. 127:711-717.
12. Lobo, E. D., R. Y. Hansen, and J. P. Balthasar. 2004. Antibody pharmacokinetics and pharmacodynamics. J. Pharm. Sci. 93:2645-2668.
13. NNIS System. 2003. National Nosocomial Infections Surveillance (NNIS) System report, data summary from January 1992 through June 2003. Am. J. Infect. Control 31:481-498.
14. Pollack, M. 1984. The virulence of Pseudomonas aeruginosa. Rev. Infect. Dis. 6(Suppl. 3):S617-S626.
15. Ritschel, W. A. 2003. Handbook of basic pharmacokinetics, 2nd ed. Drug Intelligence Publications, Hamilton, IL.
16. Salmun, L. M., and R. S. Geha. 1999. Safety and pharmakokinetics of a human IgM anti-lipid A monoclonal antibody in primary immune deficient patients. Internet J. Asthma Allergy Immunol. http://www.ispub.com/ostia/index. php?xmlFilePath=journals/ijaai/vol1n1/lipidapa.xml.
17. Saravolatz, L. D., N. Markowitz, M. S. Collins, D. Bogdanoff, and J. E. Pennington. 1991. Safety, pharmacokinetics, and functional activity of human anti-Pseudomonas aeruginosa monoclonal antibodies in septic and nonseptic patients. J. Infect. Dis. 164:803-806.
18. Spiegelberg, H. L. 1989. Biological role of different antibody classes. Int. Arch. Allergy Immunol. 90(Suppl. 1):22-27.
19. Weiner, L. M. 2006. Fully human therapeutic monoclonal antibodies. J. Immunother. 29:1-9.