A Bridging Study of the SYN023 on Healthy Adult Subjects

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

February 26, 2019

Primary Completion Date

June 20, 2019

Study Completion Date

February 20, 2020

Conditions
Communicable Disease TransmissionZoonotic DiseaseRabies HumanVaccine ReactionImmunisation Reaction
Interventions
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.

Trial Locations (1)

Unknown

Jilin University, Changchun

All Listed Sponsors
lead

Synermore Biologics (Suzhou) Co., Ltd.

INDUSTRY

NCT04495569 - A Bridging Study of the SYN023 on Healthy Adult Subjects | Biotech Hunter | Biotech Hunter