Linked Life Data

19451304

Source:http://linkedlifedata.com/resource/pubmed/id/19451304

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
8
pubmed:dateCreated
2009-7-20
pubmed:abstractText
KBPA-101 is a human monoclonal antibody of the immunoglobulin M isotype, which is directed against the O-polysaccharide moiety of Pseudomonas aeruginosa serotype O11. This double-blind, dose escalation study evaluated the safety and pharmacokinetics of KBPA-101 in 32 healthy volunteers aged 19 to 46 years. Each subject received a single intravenous infusion of KBPA-101 at a dose of 0.1, 0.4, 1.2, or 4 mg/kg of body weight or placebo infused over 2 h. Plasma samples for pharmacokinetic assessments were taken before infusion as well as 0.25, 0.5, 1, 2, 2.5, 4, 6, 8, 12, 24, 36, and 48 h and 4, 7, 10, and 14 days after start of dosing. Plasma concentrations of KBPA-101 were detected with mean maximum concentrations of drug in plasma of 1,877, 7,571, 24,923, and 83,197 ng/ml following doses of 0.1, 0.4, 1.2, and 4.0 mg/kg body weight, respectively. The mean elimination half-life was between 70 and 95 h. The mean volume of distribution was between 4.76 and 5.47 liters. Clearance ranged between 0.039 and 0.120 liters/h. At the highest dose of 4.0 mg/kg, plasma KBPA-101 levels were greater than 5,000 ng/ml for 14 days. KBPA-101 exhibited linear kinetics across all doses. No anti-KBPA-101 antibodies were detected after dosing in any subject. Overall, the human monoclonal antibody KBPA-101 was well tolerated over the entire dose range in healthy volunteers, and no serious adverse events have been reported.
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-11320454, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-11742943, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-14647111, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-15194830, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-15389672, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-15712103, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-16365595, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-17006705, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-17964218, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-1910070, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-6443764, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-7472821, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-8431557, http://linkedlifedata.com/resource/pubmed/commentcorrection/19451304-9388024
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
1098-6596
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
53
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
3442-6
pubmed:dateRevised
2010-9-27
pubmed:meshHeading
pubmed:year
2009
pubmed:articleTitle
Pharmacokinetics and safety profile of the human anti-Pseudomonas aeruginosa serotype O11 immunoglobulin M monoclonal antibody KBPA-101 in healthy volunteers.
pubmed:affiliation
Kenta Biotech, Rehhagstrasse 79, 3018 Bern, Switzerland. hedvika.lazar@kentabiotech.com
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Clinical Trial, Phase I