A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess the safety and tolerability of a single dose
of up to 800 mg in Part A (evaluated in planned steps of 5, 20, 50, 100, 200, 300 mg under
fasted conditions, followed by 300, 400, 600 and 800 mg HMPL-523 under fed conditions of a
standard meal, followed by multiple doses of 200, 300, 400 and 500 mg of HMPL-523 in Part B,
in healthy male volunteers.
The secondary objective is to determine the pharmacokinetic profile of single (Part A) and
multiple (Part B) oral doses of HMPL-523 in healthy male volunteers and to determine the
preliminary effect of food (Part C）