Anti-drug antibodies
PD
No ADAs were observed pre-dose in any participant. Treatment-emergent ADAs were observed in 2 of 15 participants (13% overall; 0 of 6 (0%) in cohort 1 and 2 of 9 (22%) in cohort 2). For both of these participants, ADA was first detectable at week 12 and persisted through week 29. Titers remained low and within ± 2.5-fold of the titer at the day of first ADA positivity at week 12, indicating stable immunogenicity response. No clear impact of treatment-emergent ADA on the PK and PD versus time profiles was observed, and no unique safety concerns were observed in the 2 ADA-positive participants.