TABLE 6.
Frequencies of anti-drug antibodies (ADAs) at day 28 across conditions
| Treatment arm | No. |
||
|---|---|---|---|
| Tested | Screened positive | Confirmed positive (%) | |
| Single dose | |||
| Rhu-pGSN 6 mg/kg | 2a | 0 | 0 |
| Placebo | 2 | 0 | 0 |
| Multidose | |||
| Rhu-pGSN 6 mg/kg | 6 | 1 | 1 (16.7) |
| Placebo | 2 | 0 | 0 |
| Multidose | |||
| Rhu-pGSN 12 mg/kg | 6 | 2 | 0 |
| Placebo | 2 | 2 | 0 |
| Multidose | |||
| Rhu-pGSN 24 mg/kg | 6 | 6 | 2 (33.3) |
| Placebo | 2 | 0 | 0 |
| All multidose | |||
| Rhu-pGSN | 18 | 9 | 3 (16.7) |
| Placebo | 6 | 2 | 0 |
| All subjects | |||
| Rhu-pGSN | 20 | 9 | 3b (15) |
| Placebo | 8 | 2 | 0 |
a
Results from 4 subjects given rhu-pGSN in the single-dose cohort are missing.
b
Two rhu-pGSN recipients were confirmed positive at baseline (predose), but neither was positive at day 28.