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Immunoglobulin

SYN023 for Post-Exposure Prophylaxis (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 4, 8, 15, 29, 43, 71, 99, 127, 155, 183, 274 and 365 for reporting.

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 more

Secondary 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 more

Side effects data

From 2022 Phase 3 trial • 1000 Patients • NCT04644484

35%

Administration site swelling

Administration site pain

Administration site erythema

Headache

Vaccination site pain

Fever

Cough

Oropharyngeal pain

Running nose

Dizziness

Diarrhea

Upper respiratory tract infection

Administration site pruritus

Vaccination site Pruritus

Dry Throat

Bronchitis

Nausea

Abdominal pain

Epigastric pain

Myalgia

Muscular weakness

Hypertension

Infectious pneumonitis

Asthenia

Mouth ulceration

Back Pain

Pruritus

Chills

100%

80%

60%

40%

20%

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