TABLE 1.
Baseline characteristics of subjects in the part A single-dose study
| Characteristic | Value for subjects receivinga
: |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 16) | Durlobactam |
||||||||
| Cohort 1, 0.25 g (n = 6) | Cohort 2, 0.5 g (n = 6) | Cohort 3, 1.0 g (n = 6) | Cohort 4, 1.0 g (n = 6) | Cohort 5, 2.0 g (n = 6) | Cohort 6, 4.0 g (n = 6) | Cohort 7, 8.0 g (n = 6) | Cohort 8,b 1.0 g (n = 6) | ||
| Age (yr) | |||||||||
| Mean ± SD | 33 ± 16 | 24 ± 4 | 31 ± 13 | 31 ± 13 | 31 ± 12 | 31 ± 8 | 21 ± 2 | 25 ± 3 | 70 ± 3 |
| Range | 20–74 | 19–31 | 20–54 | 18–54 | 21–54 | 23–46 | 19–24 | 21–28 | 66–74 |
| No. (%) of male subjects | 11 (70) | 3 (50) | 3 (50) | 3 (50) | 5 (83) | 3 (50) | 5 (83) | 2 (33) | 5 (83) |
| No. (%) of Hispanic or Latino subjects | 2 (13) | 0 | 2 (33) | 0 | 0 | 0 | 0 | 0 | 0 |
| No. (%) of subjects by race | |||||||||
| White | 15 (94) | 4 (67) | 3 (50) | 5 (83) | 6 (100) | 4 (67) | 2 (33) | 5 (83) | 5 (83) |
| Asian | 0 | 1 (17) | 1 (17) | 1 (17) | 0 | 2 (33) | 1 (17) | 1 (17) | 1 (17) |
| Black | 1 (6) | 0 | 0 | 0 | 0 | 0 | 2 (33) | 0 | 0 |
| Other | 0 | 1 (17) | 2 (33) | 0 | 0 | 0 | 1 (16) | 0 | 0 |
| Mean ± SD wt (kg) | 77 ± 13 | 66 ± 14 | 65 ± 7 | 67 ± 8 | 72 ± 12 | 81 ± 17 | 74 ± 17 | 68 ± 16 | 85 ± 10 |
| Mean ± SD BMIc (kg/m2) | 25 ± 3.4 | 22 ± 2.7 | 22 ± 1.7 | 23 ± 1.6 | 24 ± 2.7 | 27 ± 3.1 | 24 ± 2.9 | 23 ± 3.5 | 27 ± 2.4 |
a
Cohort 4 received a 2-h i.v. infusion; all other cohorts received a 3-h i.v. infusion.
b
Cohort 8 consisted of elderly subjects >65 years of age.
c
BMI, body mass index.