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

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.

Ms. hebr. oct. 101 - Maʻarekhet ha-Elohut

Vorbesitzer: Abraham Merzbacher

Inc. fol. 101 Bd. 1 (Ausst. 120) - Genesis - Psalmi

Vorbesitzer: Leonhardstift Frankfurt am Main;

Inc. fol. 101 Bd. 2 (Ausst. 120) - Proverbia - Apocalypsis

Vorbesitzer: Leonhardstift Frankfurt am Main;

Inc. fol. 101 (Ausst. 120) - Gutenberg-Bibel

Rubr. Kapitelanfänge mit roten und blauen Init.; Vorbesitzer: Leonhardstift Frankfurt am Main

Ms. Barth. 101 - Theologische Sammelhandschrift

Vorbesitzer: Bartholomaeusstift Frankfurt am Main

Na 1 Nachlass Max Horkheimer, 325 - Korrespondenzen u.a. mit Frances Bartlett Kinne und Otto Kirchheimer (p. V 101, 1-197)

75 Briefe mit Beilagen zwischen Prof. Frances Bartlett Kinne und Max Horkheimer, 1956-1973; 7 Briefe mit Beilagen zwischen Prof. Otto Kirchheimer und Max Horkheimer, 1952-1954; 19 Briefe mit Beilagen zwischen Prof. Guido Kisch und Max Horkheimer, 1955-1956; 23 Briefe mit Beilagen zwischen Walter Kittel (Oberbaurat i. R.), 1964-1973; 14 Briefe mit Beilagen zwischen Jules Klanfer und Max Horkheimer, 1963-1964; 4 Briefe mit Beilagen zwischen Prof. Otto Klineberg und Max Horkheimer, 1960-1961; 1 Brief von Max Horkheimer an Otto Klineberg (Psychologe), 22.6.1960;

Na 50 Nachlass Arthur Schopenhauer - 'Schopenhauer-Archiv', 101 - Dankesschreiben anlässlich der Zusendung eines Leuchters

u.a.: Ankündigung des Besuchs in Hamburg;

Ms. Praed. 101 - Metamorphoseon libri XV adiectis glossis marginalibus et interlinearibus

Vorbesitzer: Dominikanerkloster Frankfurt am Main

Ms. lat. qu. 101 - Capitulatio in libros XXIV epistolarum rerum familiarium

Vorbesitzer: Theodor Oehler; Karl Gottlieb Reinhard Oehler