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Table 3 PK parameters for single dose rHuIL-12 in the FIH and Phase 1b expansion studies

From: Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects

 

PK Parameter

Study

Dose

Statistic

Initial T ½

Terminal T ½

T max

C max

AUC 0-t

(μg)

 

(h)

(h)

(h)

(pg/mL)

(h*pg/mL)

FIH

       
 

2

N

4

4

4

4

4

  

Mean ± SD

NR

NR

8.00 (8.00 – 8.00)a

5.55 ± 1.34

45.28 ± 11.30

 

5

N

4

4

4

4

4

  

Mean ± SD

NR

NR

5.00 (2.00 - 8.00)a

16.52 ± 2.87

154.22 ± 56.41

 

10

N

3

4

4

4

4

  

Mean ± SD

11.8 ± 1.79

89.56 ± 57.61

8.00 (5.00 - 8.00)a

26.39 ± 3.90

1169.86 ± 513.05

 

12

N

4

4

4

4

4

  

Mean ± SD

9.23 ± 5.78

48.92 ± NR

8.00 (8.00 - 12.00)a

45.41 ± 43.46

790.74 ± 305.24

 

15

N

4

4

4

4

4

  

Mean ± SD

8.71 ± 6.54

90.19 ± 68.49

5.00 (5.00 - 8.00)a

96.81 ± 57.12

1436.67 ± 602.18

 

20

N

1

1

1

1

1

  

Mean ± SD

7.22

83.05

12.00b

39.50

970.58

Expansion

       
 

12

N

27

10

32

32

32

  

Mean ± SD

8.74 ± 4.73

56.92 ± 42.20

8.00 (2.00 – 24.00)a

57.67 ± 49.84

1016.07 ± 612.97

  1. Abbreviations: N number of subjects with sufficient data, NR not reported due to insufficient data, N/A not applicable, SD standard deviation.
  2. aAll data are means (±SD), except for Tmax, which is presented as median (range).
  3. bOnly 1 subject, range N/A.