Table 2. Subject baseline demographics and disease characteristics in Part III; MAD.
| PART III MAD |
HCV GT1 | HCV GT1 + comp cirrhosis | HCV GT2 | HCV GT3 | HCV GT4–6a | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo fed | AL-335 400 mg fed | AL-335 800 mg fed | AL-335 1,200 mg fed | Placebo fed | AL-335 800 mg fed | Placebo fed | AL-335 800 mg fed | Placebo fed | AL-335 800 mg fed | Placebo fed | AL-335 800 mg fed | ||
| N | 6 | 8 | 8 | 8 | 2 | 8 | 2 | 8 | 2 | 8 | 1 | 3 | 64 |
| Age (years), mean (SD) | 41.7 (9.8) | 38.6 (15.0) | 38.3 (11.2) | 37.9 (12.1) | 55.5 (2.1) | 48.4 (13.4) | 38.0 (2.8) | 41.8 (11.4) | 44.0 (5.7) | 38.9 (4.1) | 48.0 (N/A) | 46.3 (8.6) | 41.6 (11.0) |
| Male, n (%) | 6 (100) | 5 (62.5) | 7 (87.5) | 7 (87.5) | 2 (100) | 5 (62.5) | 1 (50.0) | 8 (100) | 2 (100) | 8 (100) | 1 (100) | 2 (66.7) | 54 (84.4) |
| Race, n (%) | |||||||||||||
| White | 6 (100) | 8 (100) | 8 (100) | 8 (100) | 2 (100) | 8 (100) | 2 (100) | 8 (100) | 2 (100) | 8 (100) | 1 (100) | 2 (66.7) | 63 (98.4) |
| Black/African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33.3) | 1 (1.6) |
| Ethnicity, n (%) | |||||||||||||
| Not Hispanic or Latino | 6 (100) | 8 (100) | 8 (100) | 8 (100) | 2 (100) | 8 (100) | 2 (100) | 8 (100) | 2 (100) | 8 (100) | 1 (100) | 3 (100) | 64 (100) |
| BMI (kg/m2), mean (SD) | 25.3 (3.0) | 28.1 (3.7) | 28.9 (4.1) | 24.7 (2.6) | 27.1 (1.4) | 24.3 (4.5) | 32.5 (2.9) | 26.9 (3.4) | 24.4 (1.9) | 24.7 (3.4) | 23.1 (N/A) | 27.1 (3.6) | 26.3 (3.8) |
| Mean HCV viral load (log10 IU/mL) | 5.8 | 6.2 | 6.3 | 5.9 | 5.8 | 5.9 | 6.2 | 6.5 | 5.0 | 6.3 | 6.3 | 5.9 | N/A |
aAll randomized subjects in the HCV GT4–6 cohort were infected with GT4.
BMI = body mass index, comp = compensated, GT = genotype, HCV = hepatitis C v”us, MAD = multiple ascending doses, N/A = not available, SD = standard deviation.