This study is a randomized, double-blind, active-controlled design. The goal is to evaluate the safety, pharmacokinetics and pharmacodynamic of SYN023 in combination with rabies vaccine in healthy participants under 18 years of age. Participants will: 1. Be randomly assigned to receive one of two doses of SYN023 or a dose of HRIG by intramuscular injection on Day 0, along with the first dose of the rabies vaccine. 2. Receive additional doses of the rabies vaccine on Days 3, 7, 14, and 28. 3. Have all adverse events (within 42 days) and all serious adverse events (within 126 days) after PEP administration collected and recorded. 4. Provide several blood samples for pharmacokinetics and pharmacodynamic testing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
SYN023 should be administered intramuscularly at sites distant from the vaccine injection site, either at the gluteus maximus or vastus lateralis muscles. The investigator should determine appropriate injection sites for multiple-point administration based on the participant's age and body weight. It is recommended that not more than 6 mL be administered per single gluteus maximus or vastus lateralis muscle, with not more than 4 mL per single injection site (younger children may require reduced volumes per muscle and per injection site based on individual circumstances); Injection time: Day 0.
Dosage and administration of Rabies vaccine for human use: 0.5 mL, intramuscular injection in the deltoid muscle; Injection time: Days 0, 3, 7, 14, and 28 (Essen 5-dose regimen).
HRIG should be administered intramuscularly at sites distant from the vaccine injection site, either in the gluteus maximus or vastus lateralis muscles. The investigator should determine appropriate injection sites for multiple-point administration based on the participant's age and body weight. It is recommended that not more than 6 mL be administered per single gluteus maximus or vastus lateralis muscle, with not more than 4 mL per single injection site (younger children may require reduced volumes per muscle and per injection site based on individual circumstances); Injection time: Day 0.
Yuping Dong Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou, China
Incidence of adverse drug reactions (ADRs) and adverse events (AEs)
Time frame: 42 days
Incidence of serious adverse events (SAEs)
Time frame: 126 days
Incidence of adverse reactions and adverse events
Time frame: 30 minutes and 7 days
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Days 3, 7, 14, 42, 98 and 126
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Days 3, 7, 14, 42, 98 and 126
Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA)
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). Area Under the Efficacy Curve for the GMC of RVNA from Study Day 0 to Day 14 after administration (AUEC0-14)
Time frame: Day 0 to Day 14
Maximum serum concentration (Cmax)
Cmax for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 (pre-dose), Day 3, Day 7, Day 14, Day 42, Day 98 and Day 126 post-dose, using non compartmental analysis.
Time frame: 126 days
Time to maximum concentration (Tmax)
Tmax for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 (pre-dose), Day 3, Day 7, Day 14, Day 42, Day 98 and Day 126 post-dose, using non compartmental analysis.
Time frame: 126 days
Area under the concentration-time curve (AUC0-t and AUC0-∞)
AUC0-t and AUC0-∞ for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 (pre-dose), Day 3, Day 7, Day 14, Day 42, Day 98 and Day 126 post-dose, using non compartmental analysis.
Time frame: 126 days
Terminal half-life (t1/2)
t1/2 for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 (pre-dose), Day 3, Day 7, Day 14, Day 42, Day 98 and Day 126 post-dose, using non compartmental analysis.
Time frame: 126 days
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