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Immunoglobulin
Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (ARPEP Trial)
Phase 2
Waitlist Available
Research Sponsored by Synermore Biologics Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 4, 8, 15, 29, 43, 71, 99, 127, 155, 183, 274 and 365
Awards & highlights
No Placebo-Only Group
Summary
This trial tests SYN023, a new treatment for preventing rabies after exposure. It targets people at low and normal risk of rabies exposure. SYN023 works by giving the body protective proteins to fight the virus. SYN023 has been shown to be an effective alternative to existing treatments in animal studies.
Eligible Conditions
- Post-Exposure Prophylaxis
- Rabies
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 4, 8, 15, 29, 43, 71, 99, 127, 155, 183, 274 and 365
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 4, 8, 15, 29, 43, 71, 99, 127, 155, 183, 274 and 365
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
cases of probable or confirmed rabie
geometric mean RVNA concentration (superiority)
geometric mean RVNA concentrations at D99
+1 moreSecondary study objectives
PK for AUC1-inf of SYN023 using non-compartmental analysis
PK for AUC1-t of SYN023 using non-compartmental analysis
PK for Cl of SYN023 using non-compartmental analysis
+12 moreSide effects data
From 2022 Phase 3 trial • 1000 Patients • NCT0464448435%
Administration site swelling
8%
Administration site pain
6%
Administration site erythema
5%
Headache
5%
Vaccination site pain
3%
Fever
3%
Cough
2%
Oropharyngeal pain
2%
Running nose
2%
Dizziness
2%
Diarrhea
2%
Upper respiratory tract infection
2%
Administration site pruritus
1%
Vaccination site Pruritus
1%
Dry Throat
1%
Bronchitis
1%
Nausea
1%
Abdominal pain
1%
Epigastric pain
1%
Myalgia
1%
Muscular weakness
1%
Hypertension
1%
Infectious pneumonitis
1%
Asthenia
1%
Mouth ulceration
1%
Back Pain
1%
Pruritus
1%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group: HRIG+Rabie Vaccine
Experimental Group: SYN023+Rabies Vaccine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SYN023+Rabies vaccineExperimental Treatment2 Interventions
SYN023:
* Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
* SYN023 is an equal mass mixture of CTB011 and CTB012, two monoclonal antibodies that exhibit a wide spectrum of activity against various wild-type rabies strains in vitro.
* Dosage form: 6mg/2mL, liquid,
* Dosage: 0.3 mg/kg of SYN023
* Frequency/duration: at Day 1
Rabies vaccine (RabAvert/Rabipur):
* Interventions: should be administered in deltoid muscle
* Dosage form: \>=2.5 IU, freeze-dried vaccine, reconstitute into 1mL before use
* Dosage: 1 mL after reconstitution
* Frequency/duration: at Day 1, 4, 8, 15, 29
Group II: HRIG+Rabies vaccineActive Control2 Interventions
HRIG:
* Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
* Dosage form: 150 IU/mL or 300 IU/mL, liquid,
* Dosage: 20 IU/kg of HyperRab (HRIG)
* Frequency/duration: at Day 1
Rabies vaccine (RabAvert/Rabipur):
* Interventions: should be administered in deltoid muscle
* Dosage form: \>=2.5 IU, freeze-dried vaccine, reconstitute into 1mL before use
* Dosage: 1 mL after reconstitution
* Frequency/duration: at Day 1, 4, 8, 15, 29
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SYN023
2016
Completed Phase 3
~1620
Rabies vaccine
2014
Completed Phase 4
~4070
Find a Location
Who is running the clinical trial?
Synermore Biologics Co., Ltd.Lead Sponsor
4 Previous Clinical Trials
290 Total Patients Enrolled
Synermore Biologics USA LimitedUNKNOWN
1 Previous Clinical Trials
22 Total Patients Enrolled