TABLE 2.
Demographic and baseline characteristics of study subjects
| Characteristic | AVI-6002 study |
AVI-6003 study |
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 6) | Dose (mg/kg) |
Total (n = 30) | Placebo (n = 6) | Dose (mg/kg) |
Total (n = 30) | |||||||||||
| 0.01 (n = 4) | 0.1 (n = 4) | 1 (n = 4) | 3 (n = 4) | 6 (n = 4) | 9 (n = 4) | 0.01 (n = 4) | 0.1 (n = 4) | 1 (n = 4) | 3 (n = 4) | 6 (n = 4) | 9 (n = 4) | |||||
| No. of subjects (%) | ||||||||||||||||
| Gender | ||||||||||||||||
| Male | 2 (33) | 2 (50) | 2 (50) | 2 (50) | 2 (50) | 2 (50) | 3 (75) | 15 (50) | 5 (83) | 1 (25) | 2 (50) | 2 (50) | 2 (50) | 2 (50) | 2 (50) | 16 (53) |
| Female | 4 (67) | 2 (50) | 2 (50) | 2 (50) | 2 (50) | 2 (50) | 1 (25) | 15 (50) | 1 (17) | 3 (75) | 2 (50) | 2 (50) | 2 (50) | 2 (50) | 2 (50) | 14 (47) |
| Race | ||||||||||||||||
| White | 4 (67) | 2 (50) | 2 (50) | 3 (75) | 4 (100) | 3 (75) | 2 (50) | 20 (67) | 6 (100) | 2 (50) | 1 (25) | 1 (25) | 3 (75) | 3 (75) | 2 (50) | 18 (60) |
| Black or African-American | 1 (17) | 2 (50) | 1 (25) | 1 (25) | 0 | 1 (25) | 2 (50) | 8 (27) | 0 | 2 (50) | 2 (50) | 2 (50) | 0 | 1 (25) | 2 (50) | 9 (30) |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (25) | 1 (25) | 0 | 0 | 3 (10) |
| American Indian or Alaska Native | 1 (17) | 0 | 1 (25) | 0 | 0 | 0 | 0 | 2 (7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mean (SD) | ||||||||||||||||
| Age (yr) | 28.0 (5.8) | 28.3 (5.1) | 30.3 (9.0) | 26.5 (6.0) | 23.5 (6.5) | 24.0 (5.7) | 23.3 (3.3) | 26.4 (6.0) | 33.2 (10.9) | 29.0 (8.9) | 35.0 (13.5) | 26.5 (5.3) | 32.8 (5.7) | 26.3 (7.5) | 33.8 (6.9) | 31.1 (8.7) |
| Wt (kg) | 81.6 (10.9) | 77.8 (3.3) | 75.9 (14.8) | 65.1 (7.1) | 71.1 (10.5) | 73.0 (16.2) | 66.6 (7.7) | 73.6 (11.3) | 77.3 (14.0) | 75.7 (18.4) | 76.1 (12.9) | 73.7 (21.7) | 69.0 (4.5) | 69.8 (4.6) | 70.1 (5.0) | 73.4 (12.3) |
| BMIa (kg/m2) | 27.0 (3.0) | 27.1 (2.9) | 26.4 (3.0) | 22.6 (2.7) | 24.2 (3.1) | 26.3 (5.5) | 23.7 (1.7) | 25.5 (3.4) | 24.5 (4.4) | 26.3 (4.5) | 25.3 (3.3) | 24.0 (4.5) | 25.2 (3.3) | 23.8 (2.1) | 25.2 (2.2) | 24.9 (3.4) |
| Estimated CLCR (ml/min)b | 114.1 (28.4) | 107.8 (6.9) | 104.3 (21.0) | 108.2 (20.4) | 112.8 (16.2) | 103.2 (12.9) | 111.9 (16.8) | 109.2 (18.0) | 106.7 (14.5) | 110.7 (14.4) | 109.9 (29.4) | 118.0 (4.6) | 105.1 (8.3) | 118.4 (17.2) | 98.9 (14.5) | 109.5 (17.1) |
a
BMI, body mass index.
b
The estimated creatinine clearance (CLCR) was based on a Cockcroft-Gault calculation using the lean (ideal) body weight: (140 − age) × ideal body weight (in kg) × [0.85 if female]/[72 × serum creatinine (mg/dl)].