Table 1.
Demographics and baseline characteristics of healthy volunteers (MAD phase)
| Placebo (n = 25) |
15 mg Q1W (n = 6) |
45 mg Q1W (n = 12) |
90 mg Q1W (n = 12) |
180 mg Q1W (n = 14) |
45 mg Q2W (n = 12) |
Any taldefgrobep alfa (n = 72)* |
All (N = 97)* |
||
|---|---|---|---|---|---|---|---|---|---|
| Age, years | Mean (SD) | 33.5 (8.13) | 38.0 (14.51) | 39.6 (7.25) | 37.6 (10.27) | 35.8 (8.85) | 35.5 (8.45) | 38.1 (9.50) | 36.9 (9.34) |
| Gender, n (%) | Male | 24 (96) | 5 (83) | 12 (100) | 12 (100) | 14 (100) | 12 (100) | 70 (97) | 94 (97) |
| Female | 1 (4) | 1 (17) | 0 | 0 | 0 | 0 | 2 (3) | 3 (3) | |
| Race, n (%) | White | 8 (32) | 4 (67) | 7 (58) | 9 (75) | 6 (43) | 6 (50) | 32 (44) | 40 (41) |
| Black/African American | 5 (20) | 1 (17) | 1 (8) | 1 (8) | 7 (50) | 2 (17) | 12 (17) | 17 (18) | |
| Japanese | 4 (16) | 0 | 0 | 0 | 0 | 1 (8) | 16 (22) | 20 (21) | |
| Asian other | 2 (8) | 0 | 0 | 0 | 0 | 2 (17) | 2 (3) | 4 (4) | |
| Native Hawaiian/ Other Pacific Islander | 0 | 0 |
1 (8) |
0 | 0 | 0 | 1 (1) | 1 (1) | |
| Other | 6 (24) | 1 (17) | 3 (25) | 2 (17) | 1 (7) | 1 (8) | 9 (13) | 15 (16) | |
| Weight, kg | Mean (SD) | 77.5 (13.61) | 84.80 (7.80) | 78.2 (19.06) | 84.2 (11.02) | 79.3 (9.88) | 77.8 (7.88) | 76.7 (13.35) | 76.9 (13.35) |
| BMI, kg/m2 | Mean (SD) | 25.2 (3.61) | 27.5 (2.63) | 25.7 (4.45) | 26.3 (2.60) | 25.4 (2.66) | 26.0 (2.62) | 25.0 (3.49) | 25.0 (3.50) |
*Totals include information from the Japanese 45 mg Q1W (n = 9) and 180 mg Q1W (n = 7) cohorts, values for the Japanese cohorts are not reported separately
BMI body mass index, MAD multiple ascending dose, Q1W once-weekly dosing, Q2W once every 2 weeks dosing, SD standard deviation