Trial Outcomes & Findings for A Comparison of the Safety, PD and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines (NCT NCT02956746)
NCT ID: NCT02956746
Last Updated: 2019-02-27
Results Overview
Inhibitory activity of serum in standard rabies virus inhibition test (RFFIT: Rapid Fluorescent Foci Inhibition Test) assessed as serum RVNA ≥ 0.5 IU/mL. RFFIT is a serum neutralization (inhibition) test, which means it measures the ability of rabies specific antibodies to neutralize rabies virus and prevent the virus from infecting cells. These antibodies are called rabies virus neutralizing antibodies (RVNA).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
164 participants
Primary outcome timeframe
112 days
Results posted on
2019-02-27
Participant Flow
Participant milestones
| Measure |
Imovax, SYN023
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
42
|
42
|
|
Overall Study
COMPLETED
|
38
|
37
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of the Safety, PD and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines
Baseline characteristics by cohort
| Measure |
Imovax, SYN023
n=40 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=40 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
n=42 Participants
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
n=42 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
153 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
42 participants
n=5 Participants
|
42 participants
n=4 Participants
|
164 participants
n=21 Participants
|
|
BMI
|
24.41 kg/m^2
STANDARD_DEVIATION 2.87 • n=5 Participants
|
25.74 kg/m^2
STANDARD_DEVIATION 2.96 • n=7 Participants
|
24.92 kg/m^2
STANDARD_DEVIATION 2.66 • n=5 Participants
|
24.39 kg/m^2
STANDARD_DEVIATION 3.14 • n=4 Participants
|
24.86 kg/m^2
STANDARD_DEVIATION 2.93 • n=21 Participants
|
PRIMARY outcome
Timeframe: 112 daysPopulation: Per-Protocol Population (subject with complete RVNA data).
Inhibitory activity of serum in standard rabies virus inhibition test (RFFIT: Rapid Fluorescent Foci Inhibition Test) assessed as serum RVNA ≥ 0.5 IU/mL. RFFIT is a serum neutralization (inhibition) test, which means it measures the ability of rabies specific antibodies to neutralize rabies virus and prevent the virus from infecting cells. These antibodies are called rabies virus neutralizing antibodies (RVNA).
Outcome measures
| Measure |
Imovax, SYN023
n=35 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=35 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
n=34 Participants
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
n=36 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Rabies Virus Neutralizing Activity
|
94.3 percentage of participants
|
97.1 percentage of participants
|
97.1 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 42 daysElectrocardiograms are performed to monitor subject safety. Laboratory evaluations for subject safety (adverse events) are serum chemistry evaluations, blood urea nitrogen, creatinine, bilirubin, alanine amino transferase, aspartate amino transferase, creatine phosphokinase, troponin, potassium, sodium, bicarbonate, calcium, complete blood count, platelet count, differential count, PT(prothrombin time, international normalized ratio) and PTT (partial prothrombin time and urinalyses for monitoring of safety. Additional laboratory tests may be required for evaluation of specific adverse events such as anaphylaxis and immune complex diseases. Adverse events and serious adverse events will be analyzed. A comparison of adverse event incidence between the four treatment groups will be performed.
Outcome measures
| Measure |
Imovax, SYN023
n=40 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=40 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
n=42 Participants
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
n=42 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Event Incidence of SYN023 Compared to HRIG in RabAvert and Imovax Reciptients
Unsolicited AEs
|
60 percentage of participants
|
50 percentage of participants
|
73.8 percentage of participants
|
59.5 percentage of participants
|
|
Percentage of Participants With Adverse Event Incidence of SYN023 Compared to HRIG in RabAvert and Imovax Reciptients
Solicited AEs
|
15 percentage of participants
|
47.5 percentage of participants
|
28.6 percentage of participants
|
40.5 percentage of participants
|
SECONDARY outcome
Timeframe: 112 daysPopulation: Subjects at least 1 initial anti-SYN023 assay results
Measurement of the development of anti-CTB012 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics.
Outcome measures
| Measure |
Imovax, SYN023
n=40 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=30 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
n=42 Participants
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
n=31 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Percentage of Participants With Immunogenicity: Anti-CTB012 Antibodies Positive
|
5.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: 112 daysPopulation: Subjects at least 1 initial anti-SYN023 assay results
Measurement of the development of anti-CTB011 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics.
Outcome measures
| Measure |
Imovax, SYN023
n=40 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=30 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
n=42 Participants
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
n=31 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Percentage of Participants With Immunogenicity: Anti-CTB011 Antibodies Positive
|
36.8 percentage of subjects
|
28.6 percentage of subjects
|
31.4 percentage of subjects
|
21.4 percentage of subjects
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation)
The area under the time concentration curve for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Outcome measures
| Measure |
Imovax, SYN023
n=38 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=37 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012)
AUC0-t for CTB-011
|
17549.49 day*ng/mL
Standard Deviation 8300.05
|
17318.95 day*ng/mL
Standard Deviation 7488.84
|
—
|
—
|
|
SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012)
AUC0-inf for CTB-011
|
20604.56 day*ng/mL
Standard Deviation 8904.60
|
20924.6 day*ng/mL
Standard Deviation 7041.56
|
—
|
—
|
|
SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012)
AUC0-t for CTB-012
|
22896.71 day*ng/mL
Standard Deviation 113653.68
|
23617.93 day*ng/mL
Standard Deviation 10768.7
|
—
|
—
|
|
SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012)
AUC0-inf for CTB-012
|
30943.29 day*ng/mL
Standard Deviation 11230.39
|
32495.98 day*ng/mL
Standard Deviation 11892.98
|
—
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned.
Interval from time 0 to maximum measured concentration of CTB011 and CTB012 (SYN023 components) at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Outcome measures
| Measure |
Imovax, SYN023
n=38 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=37 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Time to Maximum Concentration Tmax of CTB011 and CTB012
Tmax for CTB-011
|
6.655 day
Standard Deviation 5.957
|
6.686 day
Standard Deviation 4.741
|
—
|
—
|
|
Time to Maximum Concentration Tmax of CTB011 and CTB012
Tmax for CTB-012
|
6.892 day
Standard Deviation 6.316
|
6.932 day
Standard Deviation 4.417
|
—
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned.
Maximum concentration of of CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Outcome measures
| Measure |
Imovax, SYN023
n=38 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=37 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Maximum Serum Concentration Cmax
Cmax for CTB-011
|
686 ng/mL
Standard Deviation 292
|
610 ng/mL
Standard Deviation 240
|
—
|
—
|
|
Maximum Serum Concentration Cmax
Cmax for CTB-012
|
959 ng/mL
Standard Deviation 449
|
879 ng/mL
Standard Deviation 400
|
—
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned.
Calculated serum clearance rates for CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Outcome measures
| Measure |
Imovax, SYN023
n=38 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=37 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Serum Clearance Rate (Clp) of CTB011 and CTB012
clearance rates for CTB011
|
1.18 L/day
Standard Deviation 0.62
|
1.14 L/day
Standard Deviation 0.59
|
—
|
—
|
|
Serum Clearance Rate (Clp) of CTB011 and CTB012
clearance rates for CTB012
|
0.74 L/day
Standard Deviation 0.29
|
0.77 L/day
Standard Deviation 0.46
|
—
|
—
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned.
The time in hours to reduce the serum concnetration of CTB011 and CTB012 to 50% of the maximum serum concentration at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.
Outcome measures
| Measure |
Imovax, SYN023
n=38 Participants
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, Human Rabies Immune Globulin
n=37 Participants
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Serum Half Lives of CTB011 and CTB012
t1/2 for CTB-011
|
19.19 day
Standard Deviation 6.64
|
22.12 day
Standard Deviation 5.18
|
—
|
—
|
|
Serum Half Lives of CTB011 and CTB012
t1/2 for CTB-012
|
20.76 day
Standard Deviation 8.73
|
22.86 day
Standard Deviation 8.7
|
—
|
—
|
Adverse Events
Imovax, Human Rabies Immune Globulin
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
RabAvert, Human Rabies Immune Globulin
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Imovax, SYN023
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
RabAvert, SYN023
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imovax, Human Rabies Immune Globulin
n=40 participants at risk
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
n=42 participants at risk
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, SYN023
n=40 participants at risk
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
n=42 participants at risk
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
Investigations
Troponin I increased
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
Other adverse events
| Measure |
Imovax, Human Rabies Immune Globulin
n=40 participants at risk
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, Human Rabies Immune Globulin
n=42 participants at risk
Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
Imovax, SYN023
n=40 participants at risk
Subjects will receive SYN023 and 5 doses of Imovax rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
RabAvert, SYN023
n=42 participants at risk
Subjects will receive SYN023 and 5 doses of RabAvert rabies vaccine
SYN023: The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Imovax, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
RabAvert, human rabies immune globulin: Subjects will receive HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
17.5%
7/40 • Number of events 7 • 112 days
|
14.3%
6/42 • Number of events 7 • 112 days
|
27.5%
11/40 • Number of events 11 • 112 days
|
47.6%
20/42 • Number of events 21 • 112 days
|
|
General disorders
Influenza like illness
|
2.5%
1/40 • Number of events 1 • 112 days
|
7.1%
3/42 • Number of events 4 • 112 days
|
0.00%
0/40 • 112 days
|
7.1%
3/42 • Number of events 3 • 112 days
|
|
General disorders
Vessel puncture site bruise
|
5.0%
2/40 • Number of events 2 • 112 days
|
4.8%
2/42 • Number of events 3 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
4.8%
2/42 • Number of events 2 • 112 days
|
|
General disorders
Injection site erythema
|
7.5%
3/40 • Number of events 4 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
4.8%
2/42 • Number of events 2 • 112 days
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
9.5%
4/42 • Number of events 5 • 112 days
|
|
Gastrointestinal disorders
Injection site bruising
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
5.0%
2/40 • Number of events 2 • 112 days
|
0.00%
0/42 • 112 days
|
|
General disorders
Catheter site pain
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
General disorders
Fatigue
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
General disorders
Injection site induration
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
General disorders
Pain
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
General disorders
Vessel puncture site haemorrhage
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
General disorders
Asthenia
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
General disorders
Energy increased
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
General disorders
Injection site inflammation
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
General disorders
Injection site swelling
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Investigations
Red blood cells urine positive
|
2.5%
1/40 • Number of events 1 • 112 days
|
11.9%
5/42 • Number of events 6 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Investigations
Haemoglobin decreased
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
7.5%
3/40 • Number of events 3 • 112 days
|
4.8%
2/42 • Number of events 2 • 112 days
|
|
Investigations
Blood creatine phosphokinase increased
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Haematocrit decreased
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
5.0%
2/40 • Number of events 2 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Blood glucose increased
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
White blood cells urine positive
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Bacterial test positive
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Blood creatinine increased
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Blood pressure increased
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Crystal urine present
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Protein urine present
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.5%
1/40 • Number of events 1 • 112 days
|
4.8%
2/42 • Number of events 2 • 112 days
|
7.5%
3/40 • Number of events 3 • 112 days
|
14.3%
6/42 • Number of events 7 • 112 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
2/40 • Number of events 2 • 112 days
|
4.8%
2/42 • Number of events 2 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
4.8%
2/42 • Number of events 2 • 112 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
4.8%
2/42 • Number of events 2 • 112 days
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
2/40 • Number of events 2 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 2 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
5.0%
2/40 • Number of events 2 • 112 days
|
0.00%
0/42 • 112 days
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
5.0%
2/40 • Number of events 3 • 112 days
|
0.00%
0/42 • 112 days
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Nervous system disorders
Somnolence
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
5.0%
2/40 • Number of events 3 • 112 days
|
0.00%
0/42 • 112 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 2 • 112 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • Number of events 1 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Psychiatric disorders
Libido decreased
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Eye disorders
Eye irritation
|
2.5%
1/40 • Number of events 1 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/40 • 112 days
|
0.00%
0/42 • 112 days
|
0.00%
0/40 • 112 days
|
2.4%
1/42 • Number of events 1 • 112 days
|
Additional Information
Director of Clinical Trials
Synermore Biologics Co., Ltd.
Phone: +886 2 2659 0988
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place