Vaccine Reaction Clinical Trial
Official title:
A Phase 1 Single Center, Parallel, Open Label Bridging Study to Evaluate on the Safety, Pharmacokinetic, Pharmacodynamics and Anti-drug Antibodies (ADA) of a Single Intramuscular Doses of SYN023 in Healthy Adult Subjects
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.
In this bridging study. the Pharmacodynamic, Pharmacokinetic, Safety and ADA(Anti-Drug Antibodies) were evaluated and compared between U.S. and China subjects. ;
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