Skip to main content

Table 2 Pharmacokinetic parameters of the non-half-life extended anti-IL-6R domain and ALX-0061 in cynomolgus monkeys

From: The preclinical pharmacology of the high affinity anti-IL-6R Nanobody® ALX-0061 supports its clinical development in rheumatoid arthritis

Test item N t1/2, dominant t1/2, terminal AUCinf CL Vss
(day) (day) (μg/day/ml) (ml/day/kg) (ml/kg)
   Mean CV % Mean CV % Mean CV % Mean CV % Mean CV %
Non-half-life extended domain i.v. 0.74 mg/kg 3 - - 0.18 3 0.19 2 3971 2 227 27
ALX-0061 i.v. 0.4 mg/kg 3 1.73 11 0.53 6 16.3 14 24.8 14 42.8 8
ALX-0061 i.v. 2 mg/kg 3 5.00 15 1.44 9 193 5 10.4 6 53.7 7
ALX-0061 i.v. 10 mg/kg 2 6.61 11 - - 1136 21 9.00 21 82.7 10
  1. At day 0, three animals received the non-half-life extended domain at 0.74 mg/kg or ALX-0061 at 0.4, 2, or 10 mg/kg as a single intravenous dose, before daily subcutaneous injection with recombinant hIL-6 at 5 μg/kg for seven consecutive days. Pharmacokinetic parameters were calculated using non-compartmental analysis
  2. i.v. = intravenous; t1/2, dominant = dominant elimination half-life; t1/2, terminal = terminal elimination half-life; AUCinf = area under the concentration-time curve from time zero to infinity; CL = total body clearance; Vss = volume of distribution at steady state. CV %: coefficient of variation; N: number of animals