Table 2.
Demographic and baseline characteristics, safety population: part A, single ascending dose
| Characteristic | All placebo (n = 10) |
Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | All apitegromab (n = 30) |
|---|---|---|---|---|---|---|---|
| Apitegromab 1 mg/kg (n = 6) |
Apitegromab 3 mg/kg (n = 6) |
Apitegromab 10 mg/kg (n = 6) |
Apitegromab 20 mg/kg (n = 6) |
Apitegromab 30 mg/kg (n = 6) |
|||
| Age at informed consent (years) | |||||||
| Mean (SD) | 39.1 (12.9) | 33.7 (14.0) | 28.7 (1.5) | 32.3 (7.8) | 36.5 (12.8) | 43.8 (9.0) | 35.0 (10.7) |
| Median (min, max) | 36.0 (20, 55) | 30.0 (20, 53) | 28.0 (27, 31) | 34.5 (21, 42) | 32.5 (22, 52) | 48.5 (30, 51) | 32.5 (20, 53) |
| Gender, n (%) | |||||||
| Female | 4 (40.0) | 4 (66.7) | 1 (16.7) | 2 (33.3) | 1 (16.7) | 3 (50.0) | 11 (36.7) |
| Male | 6 (60.0) | 2 (33.3) | 5 (83.3) | 4 (66.7) | 5 (83.3) | 3 (50.0) | 19 (63.3) |
| Race, n (%) | |||||||
| White | 4 (40.0) | 0 (0) | 0 (0) | 1 (16.7) | 3 (50.0) | 1 (16.7) | 5 (16.7) |
| Black/African American | 5 (50.0) | 6 (100) | 6 (100) | 5 (83.3) | 3 (50.0) | 5 (83.3) | 25 (83.3) |
| American Indian/Alaska Native | 1 (10.0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Ethnicity, n (%) | |||||||
| Hispanic or Latino | 1 (10.0) | 0 (0) | 1 (16.7) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) |
| Not Hispanic or Latino | 9 (90.0) | 6 (100) | 5 (83.3) | 4 (66.7) | 6 (100) | 6 (100) | 27 (90) |
| Not reported | 0 (0) | 0 (0) | 0 (0) | 2 (33.3) | 0 (0) | 0 (0) | 2 (6.7) |
| Baseline body weight (kg) | |||||||
| Mean (SD) | 78.0 (10.5) | 76.9 (8.1) | 88.5 (6.5) | 86.4 (10.7) | 75.6 (16.4) | 80.8 (11.9) | 81.6 (11.7) |
| Median (min, max) | 78.6 (63.8, 95.3) | 80.5 (66.1, 85.5) | 89.4 (79.8, 98.8) | 82.7 (74.7, 102.2) | 72.5 (57.8, 104.2) | 78.3 (68.5, 102.7) | 80.9 (57.8, 104.2) |
| Baseline BMI (kg/m2) | |||||||
| Mean (SD) | 27.1 (4.7) | 27.0 (3.1) | 30.2 (3.1) | 28.3 (2.3) | 25.9 (4.1) | 27.9 (3.2) | 27.9 (3.3) |
| Median (min, max) | 26.1 (20.3, 33.8) | 26.7 (22.8, 31.8) | 30.0 (26.1, 34.4) | 28.9 (25.1, 30.9) | 24.3 (22.1, 33.1) | 27.0 (23.5, 32.9) | 27.9 (22.1, 34.4) |
Baseline is defined as data collected on day −1; if the baseline measurements on day −1 are missing, the last measurement prior to dosing served as baseline. Subjects receiving placebo are pooled together for part A (single ascending dose). Percentages are calculated using the number of subjects in the safety population in each column as the denominator
BMI body mass index, max maximum, min minimum