|Thanks. Here is the phase I.....|
>> ZGN-1061 is not readily distributed to the central nervous system and, therefore, may not be expected to result in comparable sleep-related AEs. <<
>> Four subjects (3 in the 0.6?mg ZGN-1061 group and 1 in the 1.8?mg ZGN-1061 group in the MAD phase) had D-dimer levels that exceeded the upper limit of normal (ULN) by >1.5-fold (0.81?mg/L FEU). None of these elevations was found to be indicative of VTE. These elevations occurred as a single isolated measurement, that is, occurred during the follow-up period, 28?days post-last dose (n?=?1), or coincided with known non-VTE related causes of D-dimer elevation (sampling from blocked catheter [n?=?1], tooth infection/root canal [n?=?1], multiple hematomas at venipuncture sites [n?=?1]). <<
Molecule clearly differentiates from belanorib, but it's a four week trial.