Table 3.
Summary of plasma pharmacokinetic parameters for ecnoglutide at steady state (MAD Day 36).
| Ecnoglutide dose group | ||||
|---|---|---|---|---|
| Parameter | 0.2 mg (N = 8) | 0.4 mg (N = 8) | 0.6 mg (N = 7) | |
| Cmax,ss (ng/mL) |
n | 7 | 8 | 6 |
| Mean | 25.3286 | 46.6875 | 84.7333 | |
| SD |
3.4913 |
7.0786 |
10.9237 |
|
| Tmax,ss (hr) |
n | 7 | 8 | 6 |
| Median | 72.000 | 39.042 | 12.000 | |
| AUC0-inf,ss (hr∗ng/mL) |
n | 6 | 8 | 5 |
| Mean | 6611.5447 | 11658.1612 | 21604.9215 | |
| SD |
1017.6543 |
2654.8702 |
4555.4539 |
|
| t1/2,ss (hr) |
n | 7 | 8 | 6 |
| Mean | 124.1109 | 138.0929 | 128.6007 | |
| SD |
16.5586 |
23.0285 |
13.5973 |
|
| CL/F,ss (L/hr) |
n | 6 | 8 | 5 |
| Mean | 0.0575 | 0.0669 | 0.0533 | |
| SD |
0.0092 |
0.0108 |
0.0095 |
|
| Vz/F,ss (L) |
n | 6 | 8 | 5 |
| Mean | 10.6958 | 13.2773 | 10.1639 | |
| SD |
2.1566 |
2.9711 |
1.6094 |
|
| RAAUC/D |
n | 7 | 8 | 5 |
| Mean | 1.8102 | 1.9709 | 2.2325 | |
| SD |
0.2241 |
0.2409 |
0.2413 |
|
| RACmax/D | n | 7 | 8 | 6 |
| Mean | 1.7192 | 1.9248 | 2.1125 | |
| SD | 0.2426 | 0.3312 | 0.2546 | |
Abbreviations: AUC = area under plasma time–concentration curve; Cmax = maximum plasma concentration; CL/F = apparent total body clearance; RA = accumulation ratio; SD = Standard Deviation; SS = steady state; Tmax = time to reach the maximum plasma concentration; t½ = elimination half-life. Vz/F = apparent volume of distribution.