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Table 1 Subject demographics and disease characteristics

From: Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects

 

Single ascending dosea

Multiple ascending dosea

Demographics and disease characteristics

 

IV

SC

SC Q4W × 4

Placebob

1 mg

3 mg

10 mg

30 mg

10 mg

30 mg

Placebo

3 mg

10 mg

20 mg

 

(N = 12)

(N = 6)

(N = 6)

(N = 5)

(N = 6)

(N = 5)

(N = 6)

(N = 6)

(N = 6)

(N = 6)

(N = 6)

Age, years

25.2

35.0

30.2

22.8

46.7

31.6

28.2

54.7

53.0

48.7

52.7

 

(6.3)

(12.0)

(11.2)

(2.8)

(5.0)

(9.2)

(9.5)

(9.7)

(6.8)

(8.7)

(5.5)

Weight, kg

73.1

73.8

76.8

71.2

74.2

82.8

76.7

81.5

93.4

101

112

 

(91)

(6.5)

(7.8)

(12.2)

(10.0)

(8.9)

(10.7)

(6.1)

(18.1)

(16.5)

(10.3)

Male, %

92

100

100

100

83

100

100

17

67

50

50

Mean total WOMAC score

nac

na

na

na

na

na

na

51.1

46.3

49.8

68.7

        

(9.3)

(6.4)

(8.1)

(3.7)

Mean VAS score of patients’ disease assessments

na

na

na

na

na

na

na

35.5

52.3

48.3

59.0

        

(8.3)

(8.0)

(6.6)

(6.0)

Mean score of physician’s disease assessments

na

na

na

na

na

Na

na

2.17

2.33

2.50

2.00

        

(0.48)

(0.33)

(0.22)

(0.26)

  1. All data are mean (SD), unless stated otherwise. aHealthy volunteers and patients with knee osteoarthritis were administered single- or multiple-doses of AMG 403, respectively. bCombined intravenous (IV) and subcutaneous (SC) placebo subjects. cNot applicable for healthy volunteer subjects. Q4W once every four weeks, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, VAS visual analog scale, na not applicable