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Clinical Trial Summary

The Phase I bridging clinical trial is to evaluate on the safety, pharmacokinetics (PK), pharmacodynamics (PD) and ADA of a single intramuscular injection of recombinant anti-rabies human monoclonal antibody injection (SYN023) alone or combined with rabies vaccine in healthy subjects. The study primary purpose was to compare the pharmacokinetics (PK) between U.S and China subjects, therefore to lay a foundation for the follow-up clinical trials. The secondary purpose was to evaluate the PK, PD, Safety and ADA of SYN023 in Chinese Healthy subjects and compare with that of U.S. subjects.


Clinical Trial Description

In this bridging study. the Pharmacodynamic, Pharmacokinetic, Safety and ADA(Anti-Drug Antibodies) were evaluated and compared between U.S. and China subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04495569
Study type Interventional
Source Synermore Biologics (Suzhou) Co., Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 26, 2019
Completion date February 20, 2020

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