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Table 1 In vivo study design and sample collection in male cynomolgus monkeys

From: Correlation of pharmacodynamic activity, pharmacokinetics, and anti-product antibody responses to anti-IL-21R antibody therapeutics following IV administration to cynomolgus monkeys

Group (Dose)

Animal #

Time points

(days)

Sample collection a

A; Ab-01

(10 mg/kg, IV)

Animals 1-3

-13, 1(pre-b and 5 min post-dose), 2, 8, 15, 22, 36, 50

Animals 1-3

 

71, 92c

Animal 3

 

92, 106, 113, 134, 148c

Animal 1

B; Ab-02

(10 mg/kg, IV)

Animals 4-6

-13, 1(pre- and 5 min post-dose), 2, 8, 15, 22, 36

Animals 4-6

C; IgG control

(10 mg/kg, IV)

Animals 7-9

-13, 1(pre- and 5 min post-dose), 2, 8, 15, 22, 36

Animals 7-9

  1. a. For Groups A and B, serum was collected to assay for test article concentrations and anti-product antibodies, and whole blood was collected for the ex vivo PD assay. For Group C, only whole blood samples were collected.
  2. b. For animal 1, pre-dose day 1 samples were not collected.
  3. c. Following PD analysis at day 50, additional sampling time points were included to demonstrate reversibility of PD activity, as these animals still had suppression of rhuIL-21 stimulation at day 50.