TABLE 1.
Parameter | Value in trial 1 with:a |
Value in trial 2 with:a |
||||||||
---|---|---|---|---|---|---|---|---|---|---|
MHAA4549A |
Placebo | MHAA4549A |
Placebo | |||||||
1.5 mg/kg | 5 mg/kg | 15 mg/kg | 45 mg/kg | Overall | 8,400 mg | 10,800 mg | Overall | |||
No. of subjects randomized | 4 | 4 | 4 | 4 | 16 | 5 | 4 | 4 | 8 | 6 |
Age (yr) | 43 ± 7a | 41 ± 12 | 43 ± 14 | 40 ± 24 | 41 ± 14 | 51 ± 15 | 41 ± 15 | 34 ± 3 | 37 ± 11 | 49 ± 12 |
No. of female subjects (%) | 3 (75) | 2 (50) | 3 (75) | 2 (50) | 10 (63) | 4 (80) | 2 (50) | 2 (50) | 4 (50) | 3 (50) |
No. of White subjects (%) | 4 (100) | 4 (100) | 4 (100) | 4 (100) | 16 (100) | 5 (100) | 4 (100) | 4 (100) | 8 (100) | 6 (100) |
Height (cm) | 166 ± 14 | 165 ± 5 | 166 ± 15 | 167 ± 3 | 166 ± 10 | 164 ± 5 | 163 ± 9 | 168 ± 6 | 166 ± 7 | 168 ± 5 |
Weight (kg) | 63 ± 17 | 75 ± 9 | 66 ± 7 | 65 ± 7 | 67 ± 11 | 65 ± 3 | 69 ± 9 | 69 ± 9 | 69 ± 8 | 75 ± 11 |
BMI (kg/m2) | 23 ± 2 | 28 ± 3 | 24 ± 4 | 23 ± 3 | 25 ± 3 | 24 ± 1 | 26 ± 3 | 24 ± 3 | 25 ± 3 | 27 ± 4 |
Values are means ± SD unless otherwise noted. Trial 1, entry-into-human study; trial 2, high-dose study.