A Phase 2 interventional study of SYN023 and HRIG (HyperRab) in Rabies, sponsored by Synermore Biologics Co., Ltd.. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Synermore Biologics Co., Ltd. · Phase 2, Interventional, and Prevention
This is a Phase 2b, double blinded, randomized study of SYN023 compared to HyperRab® (a licensed Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll sequentially two different risk substrata of WHO Category 3 rabies exposure which are Low Risk Group (LRG) and Normal Risk Group (NRG). The enrollment will be stepwise while subject's data will be reviewed by data and safety monitoring board (DSMB) to confirm the safety and permit for next enrollment. Besides, rabies vaccine would be administered within 75 minutes after Study Drug in each group.
This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in the United States.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 448 is above the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Synermore Biologics Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Low Risk Group):
Subjects must meet all of the following criteria at the time of subject ID assignment:
Inclusion Criteria (Normal Risk Group)
Subjects must meet all of the following criteria at the time of subject ID assignment:
Exclusion Criteria:
Subjects must have had none of the following at the time of subject ID assignment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects were enrolled in the study sequentially into 2 different risk substrata of WHO Category 3 rabies exposure, which included Low Risk Group (LRG) and Normal Risk Group (NRG). Bites to the head, neck, genitalia arm or hand are not included in the LRG. The initial 20 subjects in the LRG were to be randomized on a 3:1 (SYN023 to Human Rabies Immune Globulin (HRIG)) ratio. The general 60 subjects in the LRG were to be allocated with a 1:1 randomization to either SYN023 or HRIG treatment arms. SYN023: * Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible * Dosage: 0.3 mg/kg of SYN023 * Frequency/duration: at Day 1 Rabies vaccine: * Interventions: should be administered in deltoid muscle * Dosage: 1 mL after reconstitution * Frequency/duration: Initial LRG subjects received 4 vaccine doses (Days 1, 4, 8,15); General LRG subjects received 5 vaccine doses (Days 1, 4, 8, 15, and 29).
Biological: SYN023 · Biological: Rabies vaccine
The subjects were enrolled in the study sequentially into 2 different risk substrata of WHO Category 3 rabies exposure, which included Low Risk Group (LRG) and Normal Risk Group (NRG). Bites to the head, neck, genitalia arm or hand are not included in the LRG. The initial 20 subjects in the LRG were to be randomized on a 3:1 (SYN023 to Human Rabies Immune Globulin (HRIG)) ratio. The general 60 subjects in the LRG were to be allocated with a 1:1 randomization to either SYN023 or HRIG treatment. HRIG: * Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible * Dosage: 20 IU/kg * Frequency/duration: at Day 1 Rabies vaccine : * Interventions: should be administered in deltoid muscle * Dosage: 1 mL after reconstitution * Frequency/duration: Initial LRG subjects received 4 vaccine doses (Days 1, 4, 8,15); General LRG subjects received 5 vaccine doses (Days 1, 4, 8, 15, and 29)
Biological: HRIG (HyperRab) · Biological: Rabies vaccine
The subjects were enrolled in the study sequentially into 2 different risk substrata of WHO Category 3 rabies exposure, which included Low Risk Group (LRG) and Normal Risk Group (NRG). The NRG were consisted of all WHO Category 3 exposure. Subjects were to be allocated with a 1:1 randomization to either SYN023 or Human Rabies Immune Globulin (HRIG) treatment arms. SYN023: * Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible * Dosage: 0.3 mg/kg of SYN023 * Frequency/duration: at Day 1 Rabies vaccine: * Interventions: should be administered in deltoid muscle * Dosage: 1 mL after reconstitution * Frequency/duration: at Day 1, 4, 8, 15, 29
Biological: SYN023 · Biological: Rabies vaccine
The subjects were enrolled in the study sequentially into 2 different risk substrata of WHO Category 3 rabies exposure, which included Low Risk Group (LRG) and Normal Risk Group (NRG). The NRG were consisted of all WHO Category 3 exposure. Subjects were to be allocated with a 1:1 randomization to either SYN023 or Human Rabies Immune Globulin (HRIG) treatment arms. HRIG: * Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible * Dosage: 20 IU/kg * Frequency/duration: at Day 1 Rabies vaccine (RabAvert/Rabipur): * Interventions: should be administered in deltoid muscle * Dosage: 1 mL after reconstitution * Frequency/duration: at Day 1, 4, 8, 15, 29
Biological: HRIG (HyperRab) · Biological: Rabies vaccine
it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
it should be administered in deltoid muscle
Also known as: RabAvert, Rabipur
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Day 8
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 99
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Day 99
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL at Study Day 99
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Day 99
Cases of Probable and Confirmed Rabies
Case Classification Human Rabies * Suspected: A case that is compatible with the clinical case definition * Probable: A suspected case (above) plus history of contact with a suspected rabid animal. * Confirmed: A suspected case that is laboratory-confirmed.
Time frame: Day 1 to Day 365
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 4
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Day 4
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 1 to Day 15 after administration (AUEC1-15)
Time frame: Day 1 to Day 15
Maximum Observed Serum Concentration (Cmax)
The Cmax of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Time of Maximum Observed Serum Concentration (Tmax)
The Tmax of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Last Time Point (AUC1-t)
The Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Last Time Point (AUC1-t) of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Infinity (AUC1-inf)
The Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Infinity (AUC1-inf) of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Terminal Half-life (t1/2)
The t1/2 of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Terminal Elimination Rate Constant (λz)
The λz of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Apparent Clearance (CL/F)
The CL/F of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Apparent Volume of Distribution (Vd/F)
The Vd/F of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Anti-CTB011 and Anti-CTB012 Antibody
Count of Subjects With Antibodies (CTB011 and CTB012) Status by Time Point
Time frame: Day 1 to Day 99
Number of Subjects With at Least 1 Adverse Event
The number of subjects with at least 1 unsolicited or solicited adverse events. Solicited adverse events: subjects were specifically asked about local adverse events (injection site pain, tenderness, redness swelling, warmth, skin disruption, regional lymphadenopathy) and non-local adverse events (headache, arthralgia, myalgia, rash, pruritus, urticaria, dyspnea, chest pain, cough, fever, chills) up to Study Day 8. Unsolicited adverse events were collected from Study Day 1 to Study Day 43.
Time frame: Solicited adverse events: Day 1 to day 8, Unsolicited adverse events：Day 1 to day 43
| Milestone | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|---|---|
| Started | 45 | 35 | 184 | 184 |
| Completed | 45 | 34 | 178 | 178 |
| Not completed | 0 | 1 | 6 | 6 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 | 4 |
| Withdrew: Death | 0 | 1 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 2 | 2 |
| Withdrew: No treatment received | 0 | 0 | 1 | 0 |
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
| IU/mL | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|---|---|
| Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8 | 4.70 ± 0.37 | 0.13 ± 0.10 | 3.30 ± 0.61 | 0.17 ± 1.39 |
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
| IU/mL | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|---|---|
| Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 99 | 0.66 ± 1.13 | 1.72 ± 1.83 | 0.97 ± 1.21 | 1.47 ± 1.60 |
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
| Participants | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|---|---|
| Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL at Study Day 99 | 30 | 28 | 138 | 142 |
Case Classification Human Rabies * Suspected: A case that is compatible with the clinical case definition * Probable: A suspected case (above) plus history of contact with a suspected rabid animal. * Confirmed: A suspected case that is laboratory-confirmed.
| participants | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|---|---|
| Cases of Probable and Confirmed Rabies | 0 | 0 | 0 | 0 |
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
| IU/mL | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|---|---|
| Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 4 | 3.30 ± 1.27 | 0.12 ± 0.36 | 3.30 ± 0.60 | 0.14 ± 0.82 |
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 1 to Day 15 after administration (AUEC1-15)
| day*IU/mL | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|---|---|
| Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA) | 42.91 ± 0.44 | 5.79 ± 1.43 | 46.00 ± 0.57 | 9.81 ± 2.29 |
The Cmax of CTB011 and CTB012 derived from non-compartmental analysis.
| ng/mL | Low Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine |
|---|---|---|
| Cmax for CTB011 | 903 ± 23.8 | 700 ± 25.9 |
| Cmax for CTB012 | 916.5 ± 31.3 | 628 ± 32.6 |
The Tmax of CTB011 and CTB012 derived from non-compartmental analysis.
| day | Low Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine |
|---|---|---|
| Tmax for CTB011 | 2.93 ± 0.23 | 2.89 ± 0.34 |
| Tmax for CTB012 | 2.87 ± 0.34 | 2.89 ± 0.34 |
The Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Last Time Point (AUC1-t) of CTB011 and CTB012 derived from non-compartmental analysis.
| day*ng/mL | Low Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine |
|---|---|---|
| AUC1-t for CTB011 | 19500 ± 22.7 | 7640 ± 33.6 |
| AUC1-t for CTB012 | 17250 ± 34.2 | 6660 ± 33.7 |
The Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Infinity (AUC1-inf) of CTB011 and CTB012 derived from non-compartmental analysis.
| day*ng/mL | Low Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine |
|---|---|---|
| AUC1-inf for CTB011 | 22200 ± 24.1 | — |
| AUC1-inf for CTB012 | 23700 ± 16.9 | — |
The t1/2 of CTB011 and CTB012 derived from non-compartmental analysis.
| day | Low Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine |
|---|---|---|
| t1/2 for CTB011 | 16.3 ± 27.7 | 16.6 |
| t1/2 for CTB012 | 16.9 ± 32.7 | 21.3 |
The λz of CTB011 and CTB012 derived from non-compartmental analysis.
| 1/day | Low Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine |
|---|---|---|
| λz for CTB011 | 0.0428 ± 27.7 | 0.0417 |
| λz for CTB012 | 0.0416 ± 32.7 | 0.0325 |
The CL/F of CTB011 and CTB012 derived from non-compartmental analysis.
| mL/day | Low Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine |
|---|---|---|
| CL/F for CTB011 | 878.5 ± 24.2 | — |
| CL/F for CTB012 | 823.5 ± 24.3 | — |
The Vd/F of CTB011 and CTB012 derived from non-compartmental analysis.
| mL | Low Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine |
|---|---|---|
| Vd/F for CTB011 | 17450 ± 29.2 | — |
| Vd/F for CTB012 | 16450 ± 17.4 | — |
Count of Subjects With Antibodies (CTB011 and CTB012) Status by Time Point
| Participants | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|
| Day 1 (baseline) — Either is positive | 41 | 46 |
| Day 1 (baseline) — Both are negative | 113 | 109 |
| Day 15 — Either is positive | 43 | 39 |
| Day 15 — Both are negative | 111 | 117 |
| Day 99 — Either is positive | 48 | 36 |
| Day 99 — Both are negative | 105 | 117 |
The number of subjects with at least 1 unsolicited or solicited adverse events. Solicited adverse events: subjects were specifically asked about local adverse events (injection site pain, tenderness, redness swelling, warmth, skin disruption, regional lymphadenopathy) and non-local adverse events (headache, arthralgia, myalgia, rash, pruritus, urticaria, dyspnea, chest pain, cough, fever, chills) up to Study Day 8. Unsolicited adverse events were collected from Study Day 1 to Study Day 43.
| Participants | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine |
|---|---|---|---|---|
| Unsolicited Treatment-Emergent Adverse Events | 9 | 11 | 35 | 28 |
| Solicited Treatment-Emergent Adverse Events | 3 | 1 | 7 | 7 |
Collected over 365 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LRG: SYN023+Rabies Vaccine | 0/45 (0%) | 0/45 (0%) | 9/45 (20%) |
| LRG: HRIG+Rabies Vaccine | 1/35 (2.9%) | 1/35 (2.9%) | 11/35 (31.4%) |
| NRG: SYN023+Rabies Vaccine | 0/183 (0%) | 1/183 (0.5%) | 40/183 (21.9%) |
| NRG: HRIG+Rabies Vaccine | 0/184 (0%) | 2/184 (1.1%) | 30/184 (16.3%) |
| Event | LRG: SYN023+Rabies Vaccine | LRG: HRIG+Rabies Vaccine | NRG: SYN023+Rabies Vaccine | NRG: HRIG+Rabies Vaccine |
|---|---|---|---|---|
| Breast cancer recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/45 | 1/35 | 0/183 | 0/184 |
| Ruptured ectopic pregnancyPregnancy, puerperium and perinatal conditions | 0/45 | 0/35 | 1/183 | 0/184 |
| LeptospirosisInfections and infestations | 0/45 | 0/35 | 0/183 | 1/184 |
| Cerebrovascular accidentNervous system disorders | 0/45 | 0/35 | 0/183 | 1/184 |
| Event | LRG: SYN023+Rabies Vaccine | LRG: HRIG+Rabies Vaccine | NRG: SYN023+Rabies Vaccine | NRG: HRIG+Rabies Vaccine |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 1/45 | 4/35 | 2/183 | 4/184 |
| Urinary tract infectionInfections and infestations | 2/45 | 0/35 | 5/183 | 2/184 |
| ChillsGeneral disorders | 2/45 | 0/35 | 0/183 | 0/184 |
| Eosinophil count increasedInvestigations | 0/45 | 0/35 | 6/183 | 0/184 |
| NasopharyngitisInfections and infestations | 0/45 | 1/35 | 3/183 | 0/184 |
| Pyelonephritis acuteInfections and infestations | 0/45 | 1/35 | 0/183 | 0/184 |
| Muscle strainInjury, poisoning and procedural complications | 0/45 | 1/35 | 0/183 | 1/184 |
| Glucose tolerance impairedMetabolism and nutrition disorders | 0/45 | 1/35 | 0/183 | 0/184 |
| HypokalaemiaMetabolism and nutrition disorders | 0/45 | 1/35 | 0/183 | 0/184 |
| HeadacheNervous system disorders | 0/45 | 1/35 | 5/183 | 5/184 |
Baseline characteristics were summarized by treatment group for all subjects in the As-treated Population. The as-treated population grouped by actual treatment received included all randomly assigned subjects with at least one dose of study treatment.
| Age, Continuous(years) | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Total |
|---|---|---|---|---|---|
| Mean | 38.0 ± 14.26 | 38.4 ± 13.73 | 31.9 ± 11.33 | 31.3 ± 12.49 | 34.9 ± 12.95 |
| Sex: Female, Male(Participants) | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Total |
|---|---|---|---|---|---|
| Female | 24 | 18 | 85 | 84 | 211 |
| Male | 21 | 17 | 98 | 100 | 236 |
| Race/Ethnicity, Customized(Participants) | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Total |
|---|---|---|---|---|---|
| Asian | 45 | 35 | 183 | 184 | 447 |
| Race/Ethnicity, Customized(Participants) | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 2 | 2 |
| Not Hispanic or Latino | 45 | 35 | 183 | 182 | 445 |
| Region of Enrollment(participants) | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Total |
|---|---|---|---|---|---|
| Philippines | 45 | 35 | 183 | 184 | 447 |
| BMI(kg/m^2) | Low Risk Group: SYN023+Rabies Vaccine | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Normal Risk Group: SYN023+Rabies Vaccine | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | Total |
|---|---|---|---|---|---|
| Mean | 24.70 ± 4.612 | 23.66 ± 4.732 | 23.89 ± 4.787 | 23.69 ± 4.573 | 24.25 ± 4.664 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2019 to primary completion in Dec 2021, 27 months.
Results were first posted in Jan 2026, 4 years after primary completion.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: SYN023
Synermore Biologics Co., Ltd.