Table 1.
Participant Demographics and Baseline Characteristics
| Part A, single ascending dose cohorts | Part B, multiple ascending dose cohorts | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=12) | 10 mg (n=6) | 30 mg (n=6) | 90 mg (n=6) | 250 mg (n=6) | 500 mg (n=6) | 500 mg Japanese (n=6) | MEDI6570 total (n=36) | Placebo (n=10) | 90 mg (n=10) | 150 mg (n=10) | 250 mg (n=10) | MEDI6570 total (n=30) | |
| Age, mean (SD), y | 57.8 (6.9) | 52.8 (10.2) | 56.7 (5.3) | 59.7 (4.7) | 59.0 (5.2) | 60.0 (5.2) | 57.5 (7.2) | 57.6 (6.6) | 59.0 (5.5) | 57.3 (6.4) | 57.5 (9.3) | 58.4 (5.8) | 57.7 (7.1) |
| Female, n (%) | 3 (25.0) | 1 (16.7) | 1 (16.7) | 5 (83.3) | 1 (16.7) | 2 (33.3) | 2 (33.3) | 12 (33.3) | 5 (50.0) | 5 (50.0) | 7 (70.0) | 8 (80.0) | 20 (66.7) |
| Race, n (%) | |||||||||||||
| Asian | 2 (16.7) | 0 | 0 | 0 | 0 | 0 | 6 (100.0) | 6 (16.7) | 0 | 0 | 0 | 0 | 0 |
| Black | 2 (16.7) | 2 (33.3) | 1 (16.7) | 0 | 1 (16.7) | 2 (33.3) | 0 | 6 (16.7) | 1 (10.0) | 0 | 0 | 4 (40.0) | 4 (13.3) |
| White | 8 (66.7) | 4 (66.7) | 5 (83.3) | 6 (100.0) | 5 (83.3) | 4 (66.7) | 0 | 24 (66.7) | 9 (90.0) | 10 (100.0) | 9 (90.0) | 6 (60.0) | 25 (83.3) |
| Ethnicity, n (%) | |||||||||||||
| Hispanic | 3 (25.0) | 0 | 1 (16.7) | 4 (66.7) | 3 (50.0) | 0 | 0 | 8 (22.2) | 6 (60.0) | 7 (70.0) | 6 (60.0) | 2 (20.0) | 15 (50.0) |
| BMI, kg/m2, mean (SD) | 29.9 (3.8) | 30.8 (4.1) | 34.4 (5.0) | 30.5 (5.1) | 31.3 (5.9) | 31.9 (4.2) | 27.7 (5.2) | 31.1 (5.0) | 33.0 (4.4) | 34.6 (6.5) | 33.0 (5.2) | 34.2 (3.7) | 33.9 (5.1) |
| Prior CAD, n (%) | 1 (8.3) | 0 | 1 (16.7) | 1 (16.7) | 0 | 1 (16.7) | 0 | 3 (8.3) | 0 | 0 | 0 | 0 | 0 |
| Hypertension, n (%) | 10 (83.3) | 1 (16.7) | 5 (83.3) | 3 (50.0) | 4 (66.7) | 6 (100.0) | 5 (83.3) | 24 (66.7) | 6 (60.0) | 7 (70.0) | 5 (50.0) | 8 (80.0) | 20 (66.7) |
| Dyslipidemia, n (%) | 8 (66.7) | 4 (66.7) | 4 (66.7) | 4 (66.7) | 4 (66.7) | 4 (66.7) | 6 (100.0) | 26 (72.2) | 6 (60.0) | 7 (70.0) | 3 (30.0) | 6 (60.0) | 16 (53.3) |
| Current smoker, n (%) | 1 (8.3) | 0 | 0 | 0 | 1 (16.7) | 2 (33.3) | 0 | 3 (8.3) | 2 (20.0) | 1 (10.0) | 1 (10.0) | 2 (20.0) | 4 (13.3) |
| Prior PCI, n (%) | 1 (8.3) | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 | 0 | 2 (5.6) | 0 | 0 | 0 | 0 | 0 |
| Prior MI, n (%) | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (2.8) | 0 | 0 | 0 | 0 | 0 |
| Prior stroke or TIA, n (%) | 0 | 1 (16.7) | 1 (16.7) | 1 (16.7) | 0 | 2 (33.3) | 0 | 5 (13.9) | 0 | 0 | 0 | 1 (10.0) | 1 (3.3) |
| Duration of T2DM, mean (SD), y | 10.4 (4.7) | 6.2 (2.5) | 12.6 (6.8) | 11.1 (5.9) | 5.2 (6.2) | 7.4 (4.5) | 15.8 (13.1) | 9.7 (7.7) | 12.0 (7.1) | 6.3 (4.8) | 10.4 (4.9) | 9.5 (5.0) | 8.7 (5.1) |
| Baseline hs‐CRP, median (IQR), mg/L | 1.8 (0.7, 3.6) | 1.6 (0.7, 3.1) | 1.5 (1.2, 2.1) | 2.8 (2.3, 5.5) | 2.1 (1.8, 2.5) | 2.0 (1.0, 4.1) | 0.7 (0.2, 1.2) | 1.9 (1.0, 2.8) | 3.6 (1.3, 8.3) | 3.4 (2.1, 5.2) | 2.0 (0.5, 3.1) | 3.6 (2.6, 5.0) | 2.8 (1.8, 5.0) |
BMI indicates body mass index; CAD, coronary artery disease; hs‐CRP, high sensitivity C‐reactive protein; IQR, interquartile range; MI, myocardial infarction; PCI, percutaneous coronary intervention; T2DM, type 2 diabetes; and TIA, transient ischemic attack.