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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