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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-Ï„,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.