TABLE 1.
A. Single ascending dose (safety analysis set) | |||||||
---|---|---|---|---|---|---|---|
MEDI1814 | |||||||
Placebo n = 12 |
25 mg IV n = 3 |
100 mg IV n = 6 |
300 mg IV n = 6 |
900 mg IV n = 6 |
1800 mg IV n = 6 |
100 mg SC n = 6 |
|
Age (years), mean (SD) | 66.3 (7.22) | 74.0 (8.89) | 66.8 (1.94) | 69.0 (6.10) | 71.8 (5.15) | 64.8 (5.91) | 69.3 (4.84) |
Female, n (%) | 7 (58.3) | 0 (0.0) | 6 (100.0) | 5 (83.3) | 4 (66.7) | 1 (16.7) | 3 (50.0) |
White, n (%) | 10 (83.3) | 1 (33.0) | 6 (100.0) | 4 (66.7) | 5 (83.3) | 6 (100.0) | 5 (83.3) |
BMI (kg/m2), mean (SD) | 26.8 (2.90) | 27.1 (3.40) | 28.2 (1.67) | 27.2 (2.74) | 24.7 (1.68) | 27.6 (3.70) | 27.8 (2.29) |
Baseline MMSE score, mean (SD) | 21.8 (3.02) | 22.0 (2.65) | 22.3 (3.27) | 22.5 (3.73) | 22.2 (2.99) | 21.0 (2.00) | 23.2 (2.04) |
B. Multiple ascending dose (safety analysis set) | |||||
---|---|---|---|---|---|
MEDI1814 | |||||
Placebo n = 8 |
300 mg IV n = 6 |
900 mg IV n = 6 |
1800 mg IV n = 6 |
200 mg SC n = 6 |
|
Age (years), mean (SD) | 70.0 (5.90) | 71.7 (6.62) | 70.8 (6.62) | 62.5 (6.16) | 69.3 (8.71) |
Female, n (%) | 5 (62.5) | 3 (50.0) | 2 (33.3) | 3 (50.0) | 5 (83.3) |
White, n (%) | 8 (100.0) | 5 (83.3) | 6 (100.0) | 6 (100.0) | 5 (83.3) |
BMI (kg/m2), mean (SD) | 27.9 (2.90) | 31.2 (0.73) | 26.2 (4.45) | 28.0 (3.93) | 30.1 (1.52) |
Baseline MMSE score, mean (SD) | 22.1 (2.48) | 19.8 (2.04) | 20.2 (1.72) | 20.0 (2.45) | 22.5 (2.59) |
Abbreviations: BMI, body mass index; IV, intravenous; MMSE, Mini‐Mental State Examination; SC, subcutaneous; SD, standard deviation.