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Table 1 Summary of demographic characteristics for subjects included in the SAD and MAD study

From: KH176 under development for rare mitochondrial disease: a first in man randomized controlled clinical trial in healthy male volunteers

 

SAD

MAD

Group I (N = 7)a

Group II (N = 7)a

Group III 100 mg BID (N = 4)

Group IV 200 mg BID (N = 4)

Group V 400 mg BID (N = 4)

Placebo (N = 6)

Age (years)

 Mean (SD)

30.4 (10.5)

32.0 (11.3)

40.8 (13.0)

34.5 (11.6)

44.0 (8.2)

44.7 (9.8)

 Median

28.0

31.0

44.0

35.0

43.0

48.5

 Range

(22–52)

(18–45)

(24–51)

(23–45)

(37–53)

(28–54)

Height (cm) at screening

 Mean (SD)

178.07 (6.56)

176.01 (8.11)

184.63 (2.81)

181.75 (5.25)

175.70 (3.18)

175.55 (8.25)

 Median

177.50

177.00

184.90

183.75

176.70

171.60

 Range

(165.7–184.5)

(163.0–187.5)

(181.5–187.2)

(174.0–185.5)

(171.1–178.3)

(170.4–191.5)

Weight (kg) at screening

 Mean (SD)

82.86 (10.56)

74.29 (12.61)

89.05 (11.84)

77.85 (11.96)

81.10 (4.82)

72.03 (6.06)

 Median

80.00

78.60

89.30

80.30

82.80

72.30

 Range

(69.8–100.0)

(55.2–88.6)

(77.2–100.4)

(61.2–89.6)

(74.2–84.6)

(62.6–78.8)

BMI (kg/m2) at screening

 Mean (SD)

26.09 (2.51)

24.01 (4.01)

26.10 (2.74)

23.60 (3.82)

26.28 (1.67)

23.43 (1.98)

 Median

26.10

22.80

26.25

24.90

26.70

23.50

 Range

(22.5–29.4)

(19.0–29.6)

(23.1–28.8)

(18.2–26.4)

(23.9–27.8)

(21.2–26.6)

Race

 White

7 (100.0%)

7 (100.0%)

4 (100.0%)

4 (100.0%)

4 (100.0%)

6 (100.0%)

  1. a6 subjects were enrolled of whom 1 withdrew and has been replaced