Table 6.
Mean CMAB008 plasma noncompartmental pharmacokinetic parameters following single doses in healthy volunteers
| Single-dose groups of CMAB008
|
|||
|---|---|---|---|
| 1 mg/kg (n=9) | 3 mg/kg (n=9) | 10 mg/kg (n=9) | |
| k (hours) | 0.0066±0.0020 | 0.0041±0.0008c | 0.0033±0.0006a,b |
| AUC0–t (µg·h/mL) | 2,375±616 | 9,037±2,761c | 41,060±7,336b,d |
| AUC0–∞ (µg·h/mL) | 2,434±692 | 9,183±2,758c | 41,687±7,599b,d |
| AUCt–∞ % (%) | 1.83±3.7 | 1.37±1.0 | 1.44±1.0 |
| MRT (hours) | 165±45 | 239±49c | 287±39a,b |
| t½ (hours) | 116±36 | 149±44c | 214±35a,b |
| CL/F (mL·h/kg) | 0.417±0.109 | 0.342±0.104 | 0.239±0.045a,b |
| Vss (mL/kg) | 77±24 | 86±18 | 75±14 |
| Cmax (µg/mL) | 22.5±4.0 | 51.6±13.0c | 218.9±47.6b,d |
| Tmax (hours) | 3±1 | 2±0 | 2±0 |
| Vz/F (mL/kg) | 90±49 | 72±15 | 75±15 |
Notes: Data expressed as mean±SD.
P<0.05, 3 mg/kg vs 10 mg/kg;
P<0.01, 1 mg/kg vs 10 mg/kg;
P<0.01, 3 mg/kg vs 1 mg/kg;
P<0.013 mg/kg vs 10 mg/kg.
Abbreviation: MRT, mean residence time.