TABLE 3.
Demographics—PK-evaluable and efficacy-evaluable populations.
| PK-evaluable | Efficacy-evaluable (phase 1b/2a) | ||||||
|---|---|---|---|---|---|---|---|
| Characteristics | Phase 1 (n = 24) | Phase 1b/2a (n = 25) | Placebo (n = 11) | Efzofitimod | |||
| Tertiles a | Total (n = 21) | ||||||
| [805; 3,638] (n = 7) | [3,638; 6,198] (n = 7) | [6,198; 14,860] (n = 7) | |||||
| Age (years), mean (SD) | 23.8 (3.94) | 52.3 (10.3) | 53.2 (10.4) | 55.7 (11.6) | 51.0 (10.8) | 49.9 (10.5) | 52.2 (10.7) |
| Gender, n | |||||||
| Male | 11 | 12 | 4 | 4 | 4 | 3 | 11 |
| Female | 13 | 13 | 7 | 3 | 3 | 4 | 10 |
| Body weight (kg), mean (SD) | 74 (10.5) | 97.6 (25.2) | 89 (14.15) | 87 (7.94) | 92.5 (21.9) | 116 (35.7) | 98.5 (26.7) |
| Race, n | |||||||
| White | 16 | 14 | 8 | 4 | 5 | 3 | 12 |
| Black or African American | 0 | 11 | 3 | 3 | 2 | 4 | 9 |
| Asian | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Other | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity, n | |||||||
| Not Hispanic/Latino | 22 | 24 | 10 | 7 | 7 | 7 | 21 |
| Hispanic/Latino | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
AUC, area under the concentration-time curve; PK, pharmacokinetic; SD, standard deviation.
a
Tertiles are calculated by AUC, from Day 1 to Week 24.