NCT04495569

A Bridging Study of the SYN023 on Healthy Adult Subjects

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Synermore Biologics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Communicable Disease Transmission
• Zoonotic Disease
• Rabies Human
• Vaccine Reaction
• Immunisation Reaction

Interventions

Type	Name	Description
BIOLOGICAL	recombinant anti-rabies human monoclonal antibody injection (SYN023)	The finished product of SYN023 is a mixture of two anti-rabies human monoclonal antibodies, CTB011 and CTB012 by equal quantity, containing 3.0 mg/mL active ingredients in both.
BIOLOGICAL	Rabies Vaccine	The Chinese licensed Vero Cell Freeze-dried Rabies Vaccine was injected to Cohort B as per the vaccination precedure on Days 1, 4, 8, 15, 28 respectively.

Timeline

• Start date: 2019-02-26
• Primary completion: 2019-06-20
• Completion: 2020-02-20
• First posted: 2020-08-03
• Last updated: 2021-09-29

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study