Table 2.
PK Parameters of ZYIL1 in Multiple‐Ascending‐Dose Study at Days 1 and 14
| PK Parameters | 12.5 mg (N = 6) | 50 mg (N = 6) | 100 mg (N = 6 a ) | |||
|---|---|---|---|---|---|---|
| D1 | D14 | D1 | D14 | D1 | D14 | |
| AUC0–tau (μg • h/mL) | 7.7 (1.7) | – | 31.6 (3.7) | – | 66.8 (7.3) | – |
| AUC0–24BID (μg • h/mL) | 16.9 (4) | ‐ | 65.5 (8.2) | ‐ | 145.2 (18.3) | – |
| tmax,ss1 (h) | – | 0.8 (0.5, 1) | – | 1 (1, 1) | – | 1 (0.5, 1.5) |
| Cmax,ss1 (μg/mL) | – | 2 (0.3) | – | 8.1 (1.2) | – | 16.4 (1.3) |
| tmax,ss2 (hour) | – | 1.5 (1, 2) | – | 2.1 (1) | – | 1 (0.5, 3) |
| Cmax,ss2 (μg/mL) | – | 1.8 (0.3) | – | 6.7 (1.1) | – | 16.1 (4.5) |
| AUC0–tau (μg • h/mL) | – | 12 (2.7) | – | 51.2 (7.5) | – | 92.9 (13.5) |
| AUC0–24BID (μg • h/mL) | – | 23.5 (5) | – | 97.7 (15.3) | – | 181.5 (30.4) |
| AUC0–t (μg • h/mL) | – | 28.9 (7) | – | 121.8 (21.4) | – | 216.5 (41.1) |
| AUC0–inf (μg • h/mL) | – | 29.4 (7.5) | – | 124.8 (23) | – | 219.1 (42.7) |
| RAUCtau | – | 1.6 (0.2) | – | 1.6 (0.1) | – | 1.4 (0.1) |
| RAUC24BID | – | 1.4 (0.1) | – | 1.5 (0.2) | – | 1.3 (0.1) |
AUC0–inf, area under the plasma concentration–time curve from time 0 to infinity; AUC0–24BID, area under the concentration‐time curve over 24 hour for day 1 and 14 separately; AUC0–t, area under the concentration–time curve from time 0 to the time of the last measurable concentration; AUC0–tau, area under the plasma concentration–time curve over the dosing interval; Cmax,ss1, maximum plasma concentration at steady state after the first dose; Cmax,ss2, maximum plasma concentration at steady state after the second dose; PK, pharmacokinetic; RAUC24BID, accumulation ratio for AUC0‐24BID; RAUCtau, accumulation ratio for AUCtau; SD, standard deviation; tmax,ss1, time to maximum plasma concentration at steady state after the first dose; tmax,ss2, time to maximum plasma concentration at steady state after the second dose.
Dosing interval (tau) was 12 hours.
Data are expressed as mean (SD), except for tmax, which are shown as median (min, max).
N = 6 for D1 PK parameters and N = 5 for D14 PK parameters.