Table 2 Summary of empasiprubart PK parameters after final administration (day 22) in the MAD part of the study

From: Randomized phase I trial outcomes show safe and sustainable inhibition of classical and lectin complement pathways by empasiprubart

 

Multiple doses of empasiprubart IV (2-h infusion)

10, 10, 10, 10 mg/kg

Days 1, 8, 15, 22

Cohort B1

60, 10, 10 mg/kg

Days 1, 8, 15, 22

Cohort B2

10, 50, 20 mg/kg

Days 1, 8, 15, 22

Cohort B3

Number of participants (n)

6

6

6

Cmax (µg/mL) mean (SD)

505 (42.9)

930 (134)

1111 (184)

tmax (h) median (min, max)

6.0 (3.0, 8.1)

3.0 (2.0, 8.0)

3.0 (2.0, 48.0)

AUC0–168h (µg.h/mL) mean (SD)

63,875 (6738)

120,300 (11,562)

151,445 (28,548)

t1/2 (days) mean (SD)

60.3 (20.9)

69.1 (11.0)

80.6 (29.1)

  1. Healthy participants were dosed with (1) 10 mg/kg empasiprubart or placebo on days 1, 8, 15, and 22 (cohort B1); (2) 60, 10, and 10 mg/kg empasiprubart or placebo on days 1, 8, and 22, respectively (cohort B2); or (3) 10, 50, and 20 mg/kg empasiprubart or placebo on days 1, 8, and 22, respectively (cohort B3). All doses administered as 2-h IV infusions. PK parameters were calculated and are shown as the arithmetic mean (SD).
  2. AUC0‒168h area under the serum concentration-time curve from time 0 to 168 h, Cmax maximum observed serum concentration, IV intravenous, MAD multiple ascending dose, n number of participants, PK pharmacokinetic, SD standard deviation, t1/2 apparent terminal half-life, tmax time to maximum observed serum concentration.
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