title: Pharmacokinetics of F105, a human monoclonal antibody, in persons infected with human immunodeficiency virus type 1.
abstract: F105 is a human monoclonal antibody that binds to the CD4 binding site of human immunodeficiency virus type 1 gp120 and neutralizes clinical and laboratory isolates of the human immunodeficiency virus. This phase I study investigated the disposition of the antibody in humans. F105 was administered over a 60-minute period at two dose levels, 100 and 500 mg/m2. Blood samples were obtained for up to 56 days. The clearance of the antibody was 0.33 ml/min with a corresponding half-life of approximately 13 days. Peak concentrations achieved at the higher dose level were 216.19 +/- 9.62 micrograms/ml. The disposition of the drug was linear for the doses studied. Simulations were performed to design future studies aimed at investigating the efficacy of the antibody. This study concluded that F105 can be administered as a bolus dose every 21 days.
authors.affiliation: Division of Clinical Pharmacy, University of California, San Francisco 94143-0622, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Wolfe
authors.forename: L A
authors.initials: LA
authors.lastname: Cavacini
authors.forename: M H
authors.initials: MH
authors.lastname: Samore
authors.forename: M R
authors.initials: MR
authors.lastname: Posner
authors.forename: C
authors.initials: C
authors.lastname: Kozial
authors.forename: C
authors.initials: C
authors.lastname: Spino
authors.forename: C B
authors.initials: CB
authors.lastname: Trapnell
authors.forename: N
authors.initials: N
authors.lastname: Ketter
authors.forename: S
authors.initials: S
authors.lastname: Hammer
authors.forename: J G
authors.initials: JG
authors.lastname: Gambertoglio
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000378:metabolism*; D000328:Adult; D000911:Antibodies, Monoclonal / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015497:HIV-1; D006207:Half-Life; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged
chemical_list: D000911:Antibodies, Monoclonal