A Study Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Subjects.
Status:
Completed
Trial end date:
2015-05-04
Target enrollment:
Participant gender:
Summary
This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to
determine the safety, tolerability (including pain on injection), and PK(only to be assessed
for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486
administered as a single IV injection.
Results from this study will supports further clinical development of HSK3486. This study
will be performed in compliance with the protocol, International Conference on Harmonization
Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study
concerned with the investigational product will meet the requirements of Good Manufacturing
Practice (GMP).
Phase:
Phase 1
Details
Lead Sponsor:
Sichuan Haisco Pharmaceutical Group Co., Ltd Sichuan Haisco Pharmaceutical Group Co., Ltd.