3 резултати
1. Primary objectives:
- To study the tolerance and safety of multiple oral administration of CN128 in patients with thalassemia aged 16 years and above.
- To study the pharmacokinetics of CN128 in thalassemia patients aged 16 and above by multiple oral administrations of CN128
2. Design:
The study
1. Primary objectives:
· To determine the maximum tolerated dose (MTD) of CN128 for single oral administration in thalassemia patients aged 16 and above
· To study the pharmacokinetics of CN128 in thalassemia patients aged 16 and above
2. Design:
The study is designed as a randomized, double-blind,
This is an open-label single-dose study. Approximately 40 total subjects will be enrolled. In each of the 3 hepatic impairment groups (mild hepatic dysfunction [Child-Pugh score of 5 - 6], moderate hepatic dysfunction [Child-Pugh score of 7 - 9], severe hepatic dysfunction [Child Pugh score of 10 -