Trial Outcomes & Findings for Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (NCT NCT03961555)
NCT ID: NCT03961555
Last Updated: 2026-06-29
Results Overview
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
448 participants
Primary outcome timeframe
Day 8
Results posted on
2026-06-29
Participant Flow
Participant milestones
| Measure |
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:
* 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).
|
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:
* 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).
|
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:
* 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
|
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:
* 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: at Day 1, 4, 8, 15, 29
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
35
|
184
|
184
|
|
Overall Study
COMPLETED
|
45
|
34
|
178
|
178
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
6
|
6
|
Reasons for withdrawal
| Measure |
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:
* 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).
|
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:
* 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).
|
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:
* 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
|
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:
* 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: at Day 1, 4, 8, 15, 29
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
4
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
2
|
2
|
|
Overall Study
No treatment received
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies
Baseline characteristics by cohort
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=45 Participants
This includes all participants in the Low Risk Group (LRG) receiving SYN023+Rabies Vaccine.
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=35 Participants
This includes all participants in the Low Risk Group (LRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Normal Risk Group: SYN023+Rabies Vaccine
n=183 Participants
This includes all participants in the Normal Risk Group (NRG) receiving SYN023+Rabies Vaccine.
|
Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=184 Participants
This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Total
n=447 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 14.26 • n=9 Participants
|
38.4 years
STANDARD_DEVIATION 13.73 • n=27 Participants
|
31.9 years
STANDARD_DEVIATION 11.33 • n=267 Participants
|
31.3 years
STANDARD_DEVIATION 12.49 • n=265 Participants
|
34.9 years
STANDARD_DEVIATION 12.95 • n=568 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
85 Participants
n=267 Participants
|
84 Participants
n=265 Participants
|
211 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
98 Participants
n=267 Participants
|
100 Participants
n=265 Participants
|
236 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Asian
|
45 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
183 Participants
n=267 Participants
|
184 Participants
n=265 Participants
|
447 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
45 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
183 Participants
n=267 Participants
|
182 Participants
n=265 Participants
|
445 Participants
n=568 Participants
|
|
Region of Enrollment
Philippines
|
45 participants
n=9 Participants
|
35 participants
n=27 Participants
|
183 participants
n=267 Participants
|
184 participants
n=265 Participants
|
447 participants
n=568 Participants
|
|
BMI
|
24.70 kg/m^2
STANDARD_DEVIATION 4.612 • n=9 Participants
|
23.66 kg/m^2
STANDARD_DEVIATION 4.732 • n=27 Participants
|
23.89 kg/m^2
STANDARD_DEVIATION 4.787 • n=267 Participants
|
23.69 kg/m^2
STANDARD_DEVIATION 4.573 • n=265 Participants
|
24.25 kg/m^2
STANDARD_DEVIATION 4.664 • n=568 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: 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.
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=31 Participants
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:
* 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).
|
Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=156 Participants
This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Normal Risk Group: SYN023+Rabies Vaccine
n=153 Participants
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
|
|---|---|---|---|---|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8
|
4.70 IU/mL
Geometric Coefficient of Variation 0.37
|
0.13 IU/mL
Geometric Coefficient of Variation 0.10
|
0.17 IU/mL
Geometric Coefficient of Variation 1.39
|
3.30 IU/mL
Geometric Coefficient of Variation 0.61
|
PRIMARY outcome
Timeframe: Day 99Population: 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.
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=31 Participants
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:
* 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).
|
Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=152 Participants
This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Normal Risk Group: SYN023+Rabies Vaccine
n=153 Participants
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
|
|---|---|---|---|---|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 99
|
0.66 IU/mL
Geometric Coefficient of Variation 1.13
|
1.72 IU/mL
Geometric Coefficient of Variation 1.83
|
1.47 IU/mL
Geometric Coefficient of Variation 1.60
|
0.97 IU/mL
Geometric Coefficient of Variation 1.21
|
PRIMARY outcome
Timeframe: Day 99Population: 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.
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=31 Participants
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:
* 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).
|
Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=156 Participants
This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Normal Risk Group: SYN023+Rabies Vaccine
n=154 Participants
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
|
|---|---|---|---|---|
|
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL at Study Day 99
|
30 Participants
|
28 Participants
|
142 Participants
|
138 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 365Population: 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.
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.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=31 Participants
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:
* 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).
|
Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=156 Participants
This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Normal Risk Group: SYN023+Rabies Vaccine
n=154 Participants
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
|
|---|---|---|---|---|
|
Cases of Probable and Confirmed Rabies
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 4Population: 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.
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=30 Participants
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:
* 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).
|
Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=156 Participants
This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Normal Risk Group: SYN023+Rabies Vaccine
n=154 Participants
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
|
|---|---|---|---|---|
|
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 4
|
3.30 IU/mL
Geometric Coefficient of Variation 1.27
|
0.12 IU/mL
Geometric Coefficient of Variation 0.36
|
0.14 IU/mL
Geometric Coefficient of Variation 0.82
|
3.30 IU/mL
Geometric Coefficient of Variation 0.60
|
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: 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.
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)
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=31 Participants
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:
* 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).
|
Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=156 Participants
This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Normal Risk Group: SYN023+Rabies Vaccine
n=154 Participants
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
|
|---|---|---|---|---|
|
Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA)
|
42.91 day*IU/mL
Geometric Coefficient of Variation 0.44
|
5.79 day*IU/mL
Geometric Coefficient of Variation 1.43
|
9.81 day*IU/mL
Geometric Coefficient of Variation 2.29
|
46.00 day*IU/mL
Geometric Coefficient of Variation 0.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms.
The Cmax of CTB011 and CTB012 derived from non-compartmental analysis.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=154 Participants
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
Cmax for CTB011
|
903 ng/mL
Geometric Coefficient of Variation 23.8
|
700 ng/mL
Geometric Coefficient of Variation 25.9
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax)
Cmax for CTB012
|
916.5 ng/mL
Geometric Coefficient of Variation 31.3
|
628 ng/mL
Geometric Coefficient of Variation 32.6
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms.
The Tmax of CTB011 and CTB012 derived from non-compartmental analysis.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=154 Participants
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Time of Maximum Observed Serum Concentration (Tmax)
Tmax for CTB011
|
2.93 day
Full Range 0.23 • Interval 2.58 to 14.15
|
2.89 day
Full Range 0.34 • Interval 2.6 to 13.96
|
—
|
—
|
|
Time of Maximum Observed Serum Concentration (Tmax)
Tmax for CTB012
|
2.87 day
Full Range 0.34 • Interval 2.58 to 14.02
|
2.89 day
Full Range 0.34 • Interval 2.6 to 13.93
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: The pharmacokinetics of CTB011 and CTB012 was evaluated in the LRG and NRG per-protocol populations only within the SYN023 arms.
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.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=40 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=154 Participants
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Last Time Point (AUC1-t)
AUC1-t for CTB011
|
19500 day*ng/mL
Geometric Coefficient of Variation 22.7
|
7640 day*ng/mL
Geometric Coefficient of Variation 33.6
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Last Time Point (AUC1-t)
AUC1-t for CTB012
|
17250 day*ng/mL
Geometric Coefficient of Variation 34.2
|
6660 day*ng/mL
Geometric Coefficient of Variation 33.7
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: 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.
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.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=22 Participants
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).
|
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Infinity (AUC1-inf)
AUC1-inf for CTB011
|
22200 day*ng/mL
Geometric Coefficient of Variation 24.1
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 on Study Day 1 to Infinity (AUC1-inf)
AUC1-inf for CTB012
|
23700 day*ng/mL
Geometric Coefficient of Variation 16.9
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: 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.
The t1/2 of CTB011 and CTB012 derived from non-compartmental analysis.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=38 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=1 Participants
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2)
t1/2 for CTB011
|
16.3 day
Geometric Coefficient of Variation 27.7
|
16.6 day
|
—
|
—
|
|
Terminal Half-life (t1/2)
t1/2 for CTB012
|
16.9 day
Geometric Coefficient of Variation 32.7
|
21.3 day
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: 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.
The λz of CTB011 and CTB012 derived from non-compartmental analysis.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=38 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=1 Participants
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz)
λz for CTB011
|
0.0428 1/day
Geometric Coefficient of Variation 27.7
|
0.0417 1/day
|
—
|
—
|
|
Terminal Elimination Rate Constant (λz)
λz for CTB012
|
0.0416 1/day
Geometric Coefficient of Variation 32.7
|
0.0325 1/day
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: 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.
The CL/F of CTB011 and CTB012 derived from non-compartmental analysis.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=22 Participants
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).
|
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Apparent Clearance (CL/F)
CL/F for CTB011
|
878.5 mL/day
Geometric Coefficient of Variation 24.2
|
—
|
—
|
—
|
|
Apparent Clearance (CL/F)
CL/F for CTB012
|
823.5 mL/day
Geometric Coefficient of Variation 24.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: 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.
The Vd/F of CTB011 and CTB012 derived from non-compartmental analysis.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=22 Participants
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).
|
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F)
Vd/F for CTB011
|
17450 mL
Geometric Coefficient of Variation 29.2
|
—
|
—
|
—
|
|
Apparent Volume of Distribution (Vd/F)
Vd/F for CTB012
|
16450 mL
Geometric Coefficient of Variation 17.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 99Population: 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.
Count of Subjects With Antibodies (CTB011 and CTB012) Status by Time Point
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=154 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=156 Participants
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:
* 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).
|
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.
|
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:
* 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
|
|---|---|---|---|---|
|
Anti-CTB011 and Anti-CTB012 Antibody
Day 1 (baseline) · Either is positive
|
41 Participants
|
46 Participants
|
—
|
—
|
|
Anti-CTB011 and Anti-CTB012 Antibody
Day 1 (baseline) · Both are negative
|
113 Participants
|
109 Participants
|
—
|
—
|
|
Anti-CTB011 and Anti-CTB012 Antibody
Day 15 · Either is positive
|
43 Participants
|
39 Participants
|
—
|
—
|
|
Anti-CTB011 and Anti-CTB012 Antibody
Day 15 · Both are negative
|
111 Participants
|
117 Participants
|
—
|
—
|
|
Anti-CTB011 and Anti-CTB012 Antibody
Day 99 · Either is positive
|
48 Participants
|
36 Participants
|
—
|
—
|
|
Anti-CTB011 and Anti-CTB012 Antibody
Day 99 · Both are negative
|
105 Participants
|
117 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Solicited adverse events: Day 1 to day 8, Unsolicited adverse events：Day 1 to day 43Population: All safety analyses were conducted on the as-treated population.
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.
Outcome measures
| Measure |
Low Risk Group: SYN023+Rabies Vaccine
n=45 Participants
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).
|
Low Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=35 Participants
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:
* 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).
|
Normal Risk Group: Human Rabies Immune Globulin (HRIG)+Rabies Vaccine
n=184 Participants
This includes all participants in the Normal Risk Group (NRG) receiving Human Rabies Immune Globulin (HRIG)+Rabies Vaccine.
|
Normal Risk Group: SYN023+Rabies Vaccine
n=183 Participants
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
|
|---|---|---|---|---|
|
Number of Subjects With at Least 1 Adverse Event
Unsolicited Treatment-Emergent Adverse Events
|
9 Participants
|
11 Participants
|
28 Participants
|
35 Participants
|
|
Number of Subjects With at Least 1 Adverse Event
Solicited Treatment-Emergent Adverse Events
|
3 Participants
|
1 Participants
|
7 Participants
|
7 Participants
|
Adverse Events
LRG: SYN023+Rabies Vaccine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
LRG: HRIG+Rabies Vaccine
Serious events: 1 serious events
Other events: 11 other events
Deaths: 1 deaths
NRG: SYN023+Rabies Vaccine
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
NRG: HRIG+Rabies Vaccine
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LRG: SYN023+Rabies Vaccine
n=45 participants at risk
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).
|
LRG: HRIG+Rabies Vaccine
n=35 participants at risk
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:
* 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).
|
NRG: SYN023+Rabies Vaccine
n=183 participants at risk
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
|
NRG: HRIG+Rabies Vaccine
n=184 participants at risk
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:
* Interventions: should be administered in deltoid muscle
* Dosage: 1 mL after reconstitution
* Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • Number of events 1 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • Number of events 1 • 365 days
|
0.00%
0/184 • 365 days
|
|
Infections and infestations
Leptospirosis
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • Number of events 1 • 365 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • Number of events 1 • 365 days
|
Other adverse events
| Measure |
LRG: SYN023+Rabies Vaccine
n=45 participants at risk
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).
|
LRG: HRIG+Rabies Vaccine
n=35 participants at risk
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:
* 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).
|
NRG: SYN023+Rabies Vaccine
n=183 participants at risk
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
|
NRG: HRIG+Rabies Vaccine
n=184 participants at risk
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:
* Interventions: should be administered in deltoid muscle
* Dosage: 1 mL after reconstitution
* Frequency/duration: at Day 1, 4, 8, 15, 29
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hyperchlorhydria
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
General disorders
Malaise
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
1.6%
3/184 • 365 days
|
|
General disorders
Fatigue
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
1.1%
2/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
General disorders
Injection site haematoma
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
General disorders
Injection site induration
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
General disorders
Injection site pain
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
General disorders
Vaccination site pain
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
General disorders
Vaccination site swelling
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Hepatobiliary disorders
Liver disorder
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/45 • 365 days
|
11.4%
4/35 • 365 days
|
1.1%
2/183 • 365 days
|
2.2%
4/184 • 365 days
|
|
Infections and infestations
Urinary tract infection
|
4.4%
2/45 • 365 days
|
0.00%
0/35 • 365 days
|
2.7%
5/183 • 365 days
|
1.1%
2/184 • 365 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • 365 days
|
1.6%
3/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Infections and infestations
Nail infection
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Infections and infestations
Viral rash
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
1.6%
3/183 • 365 days
|
1.6%
3/184 • 365 days
|
|
Investigations
Eosinophil count increased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
3.3%
6/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
1.6%
3/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
1.1%
2/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Investigations
White blood cell count increased
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Investigations
Blood creatinine increased
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Investigations
Blood potassium increased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Investigations
Blood urea increased
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Investigations
Differential white blood cell count abnormal
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Investigations
White blood cell count decreased
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Nervous system disorders
Headache
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • 365 days
|
2.7%
5/183 • 365 days
|
2.7%
5/184 • 365 days
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
1.1%
2/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/45 • 365 days
|
2.9%
1/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Vascular disorders
Vasculitis
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
General disorders
Chills
|
4.4%
2/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45 • 365 days
|
2.9%
1/35 • 365 days
|
1.6%
3/183 • 365 days
|
1.6%
3/184 • 365 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
1.1%
2/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
General disorders
Pyrexia
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
2.7%
5/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
1.1%
2/183 • 365 days
|
0.54%
1/184 • 365 days
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.2%
1/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.00%
0/183 • 365 days
|
0.00%
0/184 • 365 days
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/45 • 365 days
|
0.00%
0/35 • 365 days
|
0.55%
1/183 • 365 days
|
0.00%
0/184 • 365 days
|
Additional Information
Ariel Chuang / Director
Synermore Biologics Co., Ltd.
Phone: +886 22659 0988
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place