Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers
Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose
ascending study.
The trial planned to enroll fifty-six healthy volunteers. The subjects were allocated to
eight dose groups, including 0.5 mg (3+1), 1 mg (3+1), 2.5 mg (6+2), 5 mg (6+2), 10 mg (6+2),
20 mg (6+2), 35 mg(6+2) and 50 mg (6+2). Each dose group was allocated test drugs and
placebos according to the proportion of subjects in the brackets mentioned above.