Table 2.
Subject demographics by study and treatment group
| Phase 1a Single-Dose Study Treatment Groups | Phase 1b Multiple-Dose Study Treatment Groups | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BTH1677 | Placebo | BTH1677 | Placebo | |||||||||||
| 0.5 mg/kg (1-h infusion) (n = 3) | 1 mg/kg (1-h infusion) (n = 3) | 2 mg/kg (1-h infusion) (n = 4) | 4 mg/kg (1-h infusion) (n = 2) | 4 mg/kg (2-h infusion) (n = 3) | 6 mg/kg (3-h infusion) (n = 3) | All BTH1677 (n = 18) | All BTH1677 Minus 4 mg/kg 1-h Infusion Groupa (n = 16) | All Placebob (n = 6) | 1 mg/kg (1-h infusion) (n = 3) | 2 mg/kg (1-h infusion) (n = 3) | 4 mg/kg (2-h infusion) (n = 3) | All BTH1677 (n = 9) | All Placebob (n = 3) | |
| Sexc | ||||||||||||||
| Male | 2 (66.7) | 3 (100.0) | 3 (75.0) | 2 (100.0) | 2 (66.7) | 1 (33.3) | 13 (72.2) | 11 (68.8) | 6 (100.0) | 1 (33.3) | 1 (33.3) | 2 (66.7) | 4 (44.4) | 1 (33.3) |
| Female | 1 (33.3) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 1 (33.3) | 2 (66.7) | 5 (27.8) | 5 (31.2) | 0 (0.0) | 2 (66.7) | 2 (66.7) | 1 (33.3) | 5 (55.6) | 2 (66.7) |
| Racec | ||||||||||||||
| Caucasian | 3 (100.0) | 1 (33.3) | 3 (75.0) | 2 (100.0) | 2 (67.7) | 2 (67.7) | 13 (72.2) | 11 (68.8) | 5 (83.3) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 8 (88.9) | 2 (66.7) |
| African-American | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 1 (33.3) | 3 (16.7) | 3 (18.8) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hispanic | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 1 (6.2) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 1 (11.1) | 1 (33.3) |
| Asian | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 1 (6.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Age (years) | ||||||||||||||
| Mean | 27.7 | 27.0 | 27.5 | 19.5 | 26.3 | 23.0 | 25.1 | 26.4 | 28.0 | 26.0 | 21.7 | 36.3 | 28.0 | 23.7 |
| SDd | 12.5 | 8.7 | 11.2 | 2.1 | 10.4 | 3.6 | 8.6 | 8.7 | 8.8 | 12.1 | 2.1 | 10.8 | 10.5 | 4.0 |
| Median | 22.0 | 23.0 | 23.5 | 19.5 | 23.0 | 22.0 | 22.4 | 23.0 | 24.5 | 19.0 | 21.0 | 41.0 | 24.0 | 23.0 |
| Min, Max | 19, 42 | 21, 37 | 19, 44 | 18, 21 | 18, 38 | 20, 27 | 18, 44 | 18, 44 | 21, 43 | 19, 40 | 20, 24 | 24, 44 | 19, 44 | 20, 28 |
| Weight (kg) | ||||||||||||||
| Mean | 92.37 | 79.43 | 79.70 | 91.30 | 67.33 | 72.23 | 79.75 | 78.31 | 84.48 | 67.50 | 65.70 | 81.27 | 71.49 | 67.30 |
| SDd | 12.208 | 23.133 | 20.112 | 8.202 | 10.748 | 21.134 | 16.585 | 17.856 | 23.531 | 6.062 | 8.072 | 9.139 | 10.037 | 16.543 |
| Median | 86.50 | 83.60 | 80.50 | 91.30 | 72.30 | 66.30 | 79.48 | 79.15 | 80.45 | 64.00 | 68.10 | 83.90 | 71.10 | 58.00 |
| Min | 84.2 | 54.5 | 56.6 | 85.5 | 55.0 | 54.7 | 55.5 | 54.5 | 61.7 | 64.0 | 56.7 | 71.1 | 56.7 | 57.5 |
| Max | 106.4 | 100.2 | 101.2 | 97.1 | 74.7 | 95.7 | 106.4 | 106.4 | 122.7 | 74.5 | 72.3 | 88.8 | 88.8 | 86.4 |
Min minimum, Max maximum
aDuring the Phase 1a study, infusion rate was shown to have an effect on infusion-related AEs which became evident at the 4 mg/kg dose. This resulted in extending infusion time from 1 h to 2 h for a second 4-mg/kg cohort and to 3 h for the 6-mg/kg cohort. This subgroup analysis eliminates the 4-mg/kg 1-h infusion subjects shown to have AEs due to the infusion rate.
bFor subjects receiving placebo, infusion time matched that of the corresponding treatment group.
cData presented as the number (percent) of subjects.
dStandard deviation.