Skip to main content

Table 3 Pharmacokinetic data after intravenous and subcutaneous administration of AMG 108

From: A randomized, double-blind study of AMG 108 (a fully human monoclonal antibody to IL-1R1) in patients with osteoarthritis of the knee

  AMG 108 dose and route of administration
  100 mg IV 300 mg IV 300 mg SC 75 mg SC
Day 1 (first dose) (n = 12) (n = 12) (n = 12) (n = 12)
    C max (n M ; mean (SD)) 312 (72) 806 (112) 220 (58) 26.7 (12.9)
    T max (hr; median (range)) 1.0 (0.5-24.0) 1.0 (0.5-12.0) 144 (144-335) 144 (48-145)
    AUC 0-τ (n M ; mean (SD)) 2,580 (665) 8,280 (1,690) 4,230 (1,210) 244 (156)
    Trough concentration (n M ; mean (SD)) 14.9 (15.2) 148 (48) 96.3 (38.3) BQL
Day 56 (third dose) (n = 12) (n = 8)a (n = 12) (n = 6)a
    C max (n M ; mean (SD)) 315 (91) 960 (192) 397 (123) 41.4 (11.1)
    T max (hr; median (range)) 0.51 (0.50-8.0) 0.51 (0.50-8.1) 168 (48-336) 48 (48-169)
    AUC 0-τ (n M ; mean (SD)) 2,700 (1,360) 12,000 (2,230) 8,610 (3,010) 449 (213)
    Trough concentration (n M , mean (SD)) 22.5 (32.3) 257 (93) 216 (100) BQL
  1. AUC0-τ,area under the concentration-time curve, estimated by using a linear/log trapezoidal method from days 1 to 28 for the first dose and days 56 to 84 for the third dose; BQL, below the quantification limit; Cmax, maximum observed serum concentration; hr, hour; IV, intravenous; nM, nanomolar; SC, subcutaneous; SD. standard deviation; Tmax, time to Cmax. aPatients who did not receive all 3 doses of study medication were excluded from group mean for day 56.