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Table 4 Maximal change from baseline in plasma Aβ42 concentration after a single intravenous dose of SHR-1707

From: Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies

 

Placebo

  

SHR-1707*

  
  

2 mg/kg

6 mg/kg

20 mg/kg

40 mg/kg

60 mg/kg

Study CHN Part 1

      

Subject No.

10

8

8

8

8

8

Baseline, pg/mL

16.2 (1.7)

15.4 (1.6)

14.3 (2.4)

15.9 (1.9)

17.5 (0.8)

17.8 (2.0)

Maximal change

from baseline, pg/mL

1.3 (2.3)

9.8 (3.6)

23.2 (8.3)

65.6 (10.0)

109.8 (53.2)

173.2 (62.4)

Study CHN Part 2

      

Subject No.

4

8

Baseline, pg/mL

13.2 (4.8)

20.1 (4.1)

Maximal change

from baseline, pg/mL

6.7 (7.2)

64.4 (9.5)

Study AUS**

      

Subject No.

6

8

8

8

Baseline, pg/mL

14.1 (2.7)

15.0 (1.0)

13.7 (2.4)

13.9 (5.4)

Maximal change

from baseline, pg/mL

1.0 (2.7)

7.6 (2.2)

61.6 (13.8)

119.5 (17.5)

  1. Data are mean (SD). * Mean Aβ42 maximal change from baseline occurred at 8 h post-dose in the 2 mg/kg groups of SHR-1707 and at 24 h post-dose in other dosing groups of SHR-1707. ** Two subjects (one each in 2 mg/kg and 20 mg/kg SHR-1707 groups, respectively) were excluded from plasma Aβ42 analysis due to abnormal PK profiles in Study AUS