Table 6.
ADA incidence and PK parameters in ADA- and ADA+ subjects
| ADA incidence in each cohort | PK parameters | ||||||
|---|---|---|---|---|---|---|---|
| Cohort, Dose | n | ADA-n (%) |
ADA+n (%) |
Elimination half-life, t1/2 (d), mean ± SD | Apparent clearance (L/d), mean ± SD | ||
| Part A: SADa | ADA- | ADA+ | ADA- | ADA+ | |||
| A, 30-mg SC | 6 | 6 (100) | 0 (0) | 25.5 ± 2.1 | NA | 0.22 ± 0.06 | NA |
| B, 90-mg SC | 6 | 2 (33) | 4 (67) | 19.4, 21.4c | 14.4 ± 2.3 | 0.24, 0.013c | 0.28 ± 0.10 |
| C, 300-mg SC | 6 | 3 (50) | 3 (50) | 28.1 ± 5.5 | 20.7 ± 8.2 | 0.19 ± 0.03 | 0.30 ± 0.12 |
| D, 300-mg IV | 6 | 1 (17) | 5 (83) | 23.3c | 18.9 ± 4.8 | 0.23c | 0.29 ± 0.22 |
| E, 750-mg IV | 6 | 2 (33) | 4 (67) | 19.4, 27.4c | 23.9 ± 9.6 | 0.21, 0.16c | 0.21 ± 0.04 |
| All BITS7201A | 30 | 14 (47) | 16 (53) | ||||
| Placebo | 10 | 9 (90) | 1 (10) | ||||
| Part B: MADb | |||||||
| F, 150-mg SC | 5 | 1 (20) | 4 (80) | ND | ND | ND | ND |
| G, 300-mg SC | 6 | 0 (0) | 6 (100) | ND | ND | ND | ND |
| H, 600-mg SC | 6 | 0 (0) | 6 (100) | ND | ND | ND | ND |
| I, 600-mg SC | n/ad | – | – | ND | ND | ND | ND |
| All BITS7201A | 17 | 1 (5.9) | 16 (94.1) | ||||
| Placebo | 5 | 4 (80) | 1 (20) | ||||
aBaseline ADA prevalence (Part A, Day 1): 3 of 39 subjects (7.7%); n = 39 because one BITS7201A-treated subject in Cohort C did not have a Day 1 sample
bBaseline ADA prevalence (Part B, Day 1): 1 of 22 subjects (4.5%)
cFor n ≤ 2, individual values are provided instead of mean ± SD
dSample not available for testing
ND, not done because only 1 subject in Part B was ADA-negative
ADA-, ADA-negative; ADA+, ADA-positive