Table I.
Flowchart of the study.
| Procedure | Screening | Experiment | ||||
|---|---|---|---|---|---|---|
| D-28 to D-2 | D-1 | D1 | D2 | D3 | D4 | |
| Informed consent | X | |||||
| Medical history | X | X | ||||
| Physical examination | X | X | X | |||
| Vital sign | X | X | X | X | ||
| Chest X-ray | X | |||||
| 12-lead ECG | X | X | X | |||
| Body weight | X | X | X | |||
| Inclusion/exclusion criteria | X | X | ||||
| Laboratory tests | ||||||
| Immunology | X | |||||
| Hematology, biochemistry, urinalysis | X | X | X | |||
| Endogenous creatinine clearance rate | X | X | X | |||
| Stay in hospital | X | X | X | X | X | |
| Drug administration | X | |||||
| Clinical observation | X | X | X | X | X | X |
| Pharmacokinetic evaluation | ||||||
| Blood sampling | X | X | ||||
| Tissue sampling | X | X | ||||
X means the procedure will be performed. ECG, electrocardiogram; D1, first day of the major experiment.