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| Name | Class |
|---|---|
| Synermore Biologics USA Limited | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk Group: SYN023+Rabies vaccine | Experimental | 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:
Rabies vaccine:
|
|
| Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies vaccine | Active Comparator | 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:
Rabies vaccine :
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYN023 | Biological | it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Day 99 |
| Cases of Probable and Confirmed Rabies | Case Classification Human Rabies
| Day 1 to Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 4 |
| Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | The Cmax of CTB011 and CTB012 derived from non-compartmental analysis. | Day 1 to Day 99 |
| Time of Maximum Observed Serum Concentration (Tmax) | The Tmax of CTB011 and CTB012 derived from non-compartmental analysis. |
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| University of Iowa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38834432 | Derived | Quiambao BP, Payumo RA, Roa C, Borja-Tabora CF, Emmeline Montellano M, Reyes MRL, Zoleta-De Jesus L, Capeding MR, Solimen DP, Barez MY, Reid C, Chuang A, Tsao E, McClain JB. A phase 2b, Randomized, double blinded comparison of the safety and efficacy of the monoclonal antibody mixture SYN023 and human rabies immune globulin in patients exposed to rabies. Vaccine. 2024 Sep 17;42(22):126018. doi: 10.1016/j.vaccine.2024.05.066. Epub 2024 Jun 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Risk Group: SYN023+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 arms. SYN023:
Rabies vaccine:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2020 | Apr 17, 2023 |
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| Normal Risk Group: SYN023+Rabies vaccine | Experimental | 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:
Rabies vaccine:
|
|
| Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies vaccine | Active Comparator | 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:
Rabies vaccine (RabAvert/Rabipur):
|
|
| HRIG (HyperRab) | Biological | it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible |
|
| Rabies vaccine | Biological | it should be administered in deltoid muscle |
|
|
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 1 to Day 15 |
| 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. | 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. | Day 1 to Day 99 |
| Terminal Half-life (t1/2) | The t1/2 of CTB011 and CTB012 derived from non-compartmental analysis. | Day 1 to Day 99 |
| Terminal Elimination Rate Constant (λz) | The λz of CTB011 and CTB012 derived from non-compartmental analysis. | Day 1 to Day 99 |
| Apparent Clearance (CL/F) | The CL/F of CTB011 and CTB012 derived from non-compartmental analysis. | Day 1 to Day 99 |
| Apparent Volume of Distribution (Vd/F) | The Vd/F of CTB011 and CTB012 derived from non-compartmental analysis. | Day 1 to Day 99 |
| Anti-CTB011 and Anti-CTB012 Antibody | Count of Subjects With Antibodies (CTB011 and CTB012) Status by Time Point | 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. | Solicited adverse events: Day 1 to day 8, Unsolicited adverse events：Day 1 to day 43 |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Clinical Research Solutions PC -Milan | Milan | Tennessee | 38358 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Baguio General Hospital and Medical Center | Baguio City | Benguet | 2600 | Philippines |
| De La Salle Health Sciences Institute Independent Ethics Committee | Cavite City | Calabarzon | 4114 | Philippines |
| Southern Philippines Medical Center | Davao City | Davao (Region XI) | 8000 | Philippines |
| Manila Doctors Hospital Institutional Review Board | Manila | National Capital Region | 1000 | Philippines |
| Asian Hospital and Medical Center | Muntinlupa | National Capital Region | 1780 | Philippines |
| Center of Excellence in Drug Research, Evaluation and Studies, Inc. | Muntinlupa | National Capital Region | 1781 | Philippines |
| Research Institute For Tropical Medicine | Muntinlupa | National Capital Region | 1781 | Philippines |
| Far Eastern University Hospital Nicanor Reyes Medical Foundation | Quezon City | National Capital Region | 1118 | Philippines |
| Mary Johnston Hospital | Manila | Philippines |
| FG001 | Low Risk Group: Human Rabies Immune Globulin (HRIG)+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 arms. HRIG:
Rabies vaccine:
|
| FG002 | Normal Risk Group: SYN023+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:
Rabies vaccine:
|
| FG003 | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine:
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Risk Group: SYN023+Rabies Vaccine | This includes all participants in the Low Risk Group (LRG) receiving SYN023+Rabies Vaccine. |
| BG001 | Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | This includes all participants in the Low Risk Group (LRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine. |
| BG002 | Normal Risk Group: SYN023+Rabies Vaccine | This includes all participants in the Normal Risk Group (NRG) receiving SYN023+Rabies Vaccine. |
| BG003 | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The primary efficacy analyses were performed and summarized for the for the Normal Risk Group per-protocol population. Results for the Low Risk Group per-protocol population are only presented in-text tables. The per-protocol population included all as-treated subjects without any major protocol deviation who had met all inclusion/exclusion criteria and received complete study treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/mL | Day 8 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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). | The primary efficacy analyses were performed and summarized for the for the Normal Risk Group per-protocol population. Results for the Low Risk Group per-protocol population are only presented in-text tables. Per-protocol population: all subjects who were randomly assigned, received the correct study drug, met inclusion/exclusion criteria, completed all rabies scheduled vaccinations, lacked major protocol deviations, had adequate wound treatment and study drug injection of all exposure sites. | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/mL | Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Primary | 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). | The primary efficacy analyses were performed and summarized for the for the Normal Risk Group per-protocol population. Results for the Low Risk Group per-protocol population are only presented in-text tables. Per-protocol population: all subjects who were randomly assigned, received the correct study drug, met inclusion/exclusion criteria, completed all rabies scheduled vaccinations, lacked major protocol deviations, had adequate wound treatment and study drug injection of all exposure sites. | Posted | Count of Participants | Participants | Day 99 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Cases of Probable and Confirmed Rabies | Case Classification Human Rabies
| The primary efficacy analyses were performed and summarized for the for the Normal Risk Group per-protocol population. Results for the Low Risk Group per-protocol population are only presented in-text tables. Per-protocol population: all subjects who were randomly assigned, received the correct study drug, met inclusion/exclusion criteria, completed all rabies scheduled vaccinations, lacked major protocol deviations, had adequate wound treatment and study drug injection of all exposure sites. | Posted | Number | participants | Day 1 to Day 365 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | The secondary efficacy analyses were performed and summarized for the for the Normal Risk Group per-protocol population. Results for the Low Risk Group per-protocol population are only presented in-text tables. Per-protocol population: all subjects who were randomly assigned, received the correct study drug, met inclusion/exclusion criteria, completed all rabies scheduled vaccinations, lacked major protocol deviations, had adequate wound treatment and study drug injection of all exposure sites. | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/mL | Day 4 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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) | The secondary efficacy analyses were performed and summarized for the for the Normal Risk Group per-protocol population. Results for the Low Risk Group per-protocol population are only presented in-text tables. Per-protocol population: all subjects who were randomly assigned, received the correct study drug, met inclusion/exclusion criteria, completed all rabies scheduled vaccinations, lacked major protocol deviations, had adequate wound treatment and study drug injection of all exposure sites. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*IU/mL | Day 1 to Day 15 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximum Observed Serum Concentration (Cmax) | The Cmax of CTB011 and CTB012 derived from non-compartmental analysis. | The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 to Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time of Maximum Observed Serum Concentration (Tmax) | The Tmax of CTB011 and CTB012 derived from non-compartmental analysis. | The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms. | Posted | Median | Full Range | day | Day 1 to Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ng/mL | Day 1 to Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms. No subjects in the NRG had sufficient data to estimate AUC1-inf. The "Number of Participants Analyzed" represents subjects who had at least one assessable result for either CTB011 or CTB012. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ng/mL | Day 1 to Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Terminal Half-life (t1/2) | The t1/2 of CTB011 and CTB012 derived from non-compartmental analysis. | The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms. Only 1 subject in the NRG had sufficient data to estimate t½. The "Number of Participants Analyzed" represents subjects who had at least one assessable result for either CTB011 or CTB012. | Posted | Geometric Mean | Geometric Coefficient of Variation | day | Day 1 to Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Terminal Elimination Rate Constant (λz) | The λz of CTB011 and CTB012 derived from non-compartmental analysis. | The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms. Only 1 subject in the NRG had sufficient data to estimate λz. The "Number of Participants Analyzed" represents subjects who had at least one assessable result for either CTB011 or CTB012. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/day | Day 1 to Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Apparent Clearance (CL/F) | The CL/F of CTB011 and CTB012 derived from non-compartmental analysis. | The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms. No subjects in the NRG had sufficient data to estimate CL/F. The "Number of Participants Analyzed" represents subjects who had at least one assessable result for either CTB011 or CTB012. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/day | Day 1 to Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Apparent Volume of Distribution (Vd/F) | The Vd/F of CTB011 and CTB012 derived from non-compartmental analysis. | The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms. No subjects in the NRG had sufficient data to estimate Vd/F. The "Number of Participants Analyzed" represents subjects who had at least one assessable result for either CTB011 or CTB012. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | Day 1 to Day 99 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Anti-CTB011 and Anti-CTB012 Antibody | Count of Subjects With Antibodies (CTB011 and CTB012) Status by Time Point | The immunogenicity of anti-SYN023 antibodies (CTB011 and CTB012) was evaluated in the NRG per-protocol populations. The "Number of Participants Analyzed" represents subjects who had at least one assessable result for either CTB011 or CTB012 on Day 1, Day 15, or Day 99. | Posted | Count of Participants | Participants | Day 1 to Day 99 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | All safety analyses were conducted on the as-treated population. | Posted | Count of Participants | Participants | Solicited adverse events: Day 1 to day 8, Unsolicited adverse events：Day 1 to day 43 |
|
365 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LRG: SYN023+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 arms. SYN023:
Rabies vaccine:
| 0 | 45 | 0 | 45 | 9 | 45 |
| EG001 | LRG: HRIG+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 arms. HRIG:
Rabies vaccine:
| 1 | 35 | 1 | 35 | 11 | 35 |
| EG002 | NRG: SYN023+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:
Rabies vaccine:
| 0 | 183 | 1 | 183 | 40 | 183 |
| EG003 | NRG: HRIG+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:
Rabies vaccine:
| 0 | 184 | 2 | 184 | 30 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Leptospirosis | Infections and infestations | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Vertigo positional | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aphthous ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyperchlorhydria | Gastrointestinal disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Injection site haematoma | General disorders | Systematic Assessment |
| ||
| Injection site induration | General disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Vaccination site pain | General disorders | Systematic Assessment |
| ||
| Vaccination site swelling | General disorders | Systematic Assessment |
| ||
| Hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic steatosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Liver disorder | Hepatobiliary disorders | Systematic Assessment |
| ||
| Allergy to arthropod bite | Immune system disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Herpes zoster | Infections and infestations | Systematic Assessment |
| ||
| Nail infection | Infections and infestations | Systematic Assessment |
| ||
| Parasitic gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Viral rash | Infections and infestations | Systematic Assessment |
| ||
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foreign body in eye | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Eosinophil count increased | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| White blood cell count increased | Investigations | Systematic Assessment |
| ||
| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood potassium increased | Investigations | Systematic Assessment |
| ||
| Blood urea increased | Investigations | Systematic Assessment |
| ||
| Differential white blood cell count abnormal | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| Hepatic enzyme increased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Glucose tolerance impaired | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gouty arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Calculus urinary | Renal and urinary disorders | Systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Allergic cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Vasculitis | Vascular disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariel Chuang / Director | Synermore Biologics Co., Ltd. | +886 22659 0988 | achuang@synermore.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2019 | Apr 17, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| OG001 | Low Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine :
|
| OG002 | Normal Risk Group: SYN023+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:
Rabies vaccine:
|
| OG003 | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine (RabAvert/Rabipur):
|
|
|
| OG001 | Low Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine :
|
| OG002 | Normal Risk Group: SYN023+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:
Rabies vaccine:
|
| OG003 | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine (RabAvert/Rabipur):
|
|
|
| OG001 | Low Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine :
|
| OG002 | Normal Risk Group: SYN023+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:
Rabies vaccine:
|
| OG003 | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine (RabAvert/Rabipur):
|
|
|
| OG001 | Low Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine :
|
| OG002 | Normal Risk Group: SYN023+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:
Rabies vaccine:
|
| OG003 | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine (RabAvert/Rabipur):
|
|
|
| OG001 | Low Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine :
|
| OG002 | Normal Risk Group: SYN023+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:
Rabies vaccine:
|
| OG003 | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+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:
Rabies vaccine (RabAvert/Rabipur):
|
|
|
|
|
|
|
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:
Rabies vaccine:
|
|
|
| OG001 | Normal Risk Group: SYN023+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:
Rabies vaccine:
|
|
|
| Normal Risk Group: SYN023+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:
Rabies vaccine:
|
|
|
| Normal Risk Group: SYN023+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:
Rabies vaccine:
|
|
|
| Normal Risk Group: SYN023+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:
Rabies vaccine:
|
|
|
| Normal Risk Group: SYN023+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:
Rabies vaccine:
|
|
|
|
|
| OG003 | Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine | This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine. |
|
|
| Both are negative |
|
| Both are negative |
|