Table 3.
Phase I 500 U/kg (n=6) |
Phase I 1000 U/kg (n=7) |
Phase I 2500 U/kg (n=8) |
Phase II 1000 U/kg (n=23) |
|
---|---|---|---|---|
Dose Frequency | every 48 h | every 48 h | every 48 h | every 24 h × 3 doses then every 48h |
Cmax after 1st Dose (mU/ml) | 6,844 (6,596–7,705) | 13,851 (11,613–16,798) | 30,691a (27,493–40,677) | 12,730 (10,609–15,574) |
AUC48h (mU*h/ml) | 48,280 (46,180–55,071) | 114,180 (102,850–120,650) | 266,260 (246,310–274,250) | 191,300 (177,510–209,160) |
AUC7d (mU*h/ml) | 210,950b (190,840–239,050) | 483,830c (426,120–510,560) | 1,107,500 (1,007,600–1,145,800) | 541,610 (491,850–599,010) |
All data are median (IQR); Cmax, maximum observed concentration after the first dose; AUC48h, area under the plasma concentration-time curve during the first 48 hours of dosing; AUC7d, cumulative area under the plasma concentration-time curve during the first 7 days of dosing.
n=7 as one patient did not have a concentration measured in first 6 hours after the dose.
n=4 as two patients received ≤ 3 doses.
n=6 as one patients received only 3 doses.