Tetanus
Conditions
Brief summary
The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.
Interventions
BIOLOGICALTNM002 (low dose)
Single dose of TNM002 administered by intramuscular injection
BIOLOGICALTNM002 (medium dose)
Single dose of TNM002 administered by intramuscular injection
BIOLOGICALTNM002 (high dose)
Single dose of TNM002 administered by intramuscular injection
BIOLOGICALHTIG
Single dose of HTIG administered by intramuscular injection
BIOLOGICALPlacebo
Single dose of placebo administered by intramuscular injection
Sponsors
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Chinese male or female adults aged ≥ 18 years; 2. Healthy volunteers or volunteers with stable chronic diseases; 3. Volunteers who provide signed written informed consent form.
Exclusion criteria
1. History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins; 2. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; 3. History of alcohol or other substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | At 24 hours post-dose | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. |
| Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose | Up to 105 (±7) days post dosing | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. |
| Maximum Concentration (Cmax) of TNM002 | Up to 105 days post dosing | The peak serum concentration of TNM002 observed after administration. |
| Time to Maximum Concentration (Tmax) of TNM002 | Up to 105 days post dosing | The time point at which the Cmax is observed following TNM002 administration. |
| Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose | The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint. |
| Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002 | Up to 105 days post dosing | The total drug exposure of TNM002 over a defined time period (from administration to the last measurable concentration), calculated as the integral of the serum concentration-time curve. |
| Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002 | Up to 105 days post dosing | The total systemic exposure of TNM002 from administration until complete elimination, calculated by combining AUC0-t and the extrapolated area from the last measurable concentration to infinity. |
| Positive Rate of ADA in Volunteers in TNM002 Groups | Up to 105 days post dosing | The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial. |
| Elimination Half-life (t1/2) of TNM002 | Up to 105 days post dosing | The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase. |
Countries
China
Participant flow
Recruitment details
A total of 240 adult participants were recruited from 4 study sites in China, from 18 April 2022 to 27 May 2022.
Pre-assignment details
There were 402 participants excluded from the trial before assignment to any arm, primarily due to failure to meet eligibility criteria (369 participants) and other (33).
Participants by arm
| Arm | Count |
|---|---|
| TNM002 5 mg Double blind, a single intramuscular injection on Day 1 | 61 |
| TNM002 10 mg Double blind, a single intramuscular injection on Day 1 | 61 |
| TNM002 15 mg Double blind, a single intramuscular injection on Day 1 | 29 |
| HTIG Double blind, a single intramuscular injection of Human Tetanus Immunoglobulin (HTIG) 250 IU on Day 1 | 59 |
| Placebo Double blind, a single intramuscular injection on Day 1 | 30 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Covid quarantine | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | TNM002 5 mg | TNM002 10 mg | TNM002 15 mg | HTIG | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 40 years of age | 38 years of age | 33 years of age | 36 years of age | 38.5 years of age | 38 years of age |
| Anti-tetanus neutralizing antibody titers | 0.4982 IU/mL STANDARD_DEVIATION 2.1697 | 0.0916 IU/mL STANDARD_DEVIATION 0.3253 | 0.0362 IU/mL STANDARD_DEVIATION 0.0583 | 0.0596 IU/mL STANDARD_DEVIATION 0.253 | 0.0738 IU/mL STANDARD_DEVIATION 0.2194 | 0.1782 IU/mL STANDARD_DEVIATION 1.125 |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 8 Participants | 26 Participants | 13 Participants | 88 Participants |
| Sex: Female, Male Male | 41 Participants | 40 Participants | 21 Participants | 33 Participants | 17 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 61 | 0 / 29 | 0 / 59 | 0 / 30 |
| other Total, other adverse events | 30 / 61 | 29 / 61 | 14 / 29 | 32 / 59 | 16 / 30 |
| serious Total, serious adverse events | 0 / 61 | 0 / 61 | 0 / 29 | 1 / 59 | 0 / 30 |
Outcome results
Primary
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level
The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL.
Time frame: At 24 hours post-dose
Population: The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TNM002 5 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 56 Participants |
| TNM002 10 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 61 Participants |
| TNM002 15 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 29 Participants |
| HTIG | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 48 Participants |
| Placebo | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 0 Participants |
Secondary
Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002
The total systemic exposure of TNM002 from administration until complete elimination, calculated by combining AUC0-t and the extrapolated area from the last measurable concentration to infinity.
Time frame: Up to 105 days post dosing
Population: Five participants were exlucded from the analysis due to model fitting failure for AUC0-∞.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNM002 5 mg | Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002 | 589000 h*ng/mL | Standard Deviation 244000 |
| TNM002 10 mg | Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002 | 1180000 h*ng/mL | Standard Deviation 416000 |
| TNM002 15 mg | Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002 | 1990000 h*ng/mL | Standard Deviation 559000 |
Secondary
Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002
The total drug exposure of TNM002 over a defined time period (from administration to the last measurable concentration), calculated as the integral of the serum concentration-time curve.
Time frame: Up to 105 days post dosing
Population: All TNM002-treated participants had evaluable post-dose concentration data for AUC analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNM002 5 mg | Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002 | 524000 h*ng/mL | Standard Deviation 231000 |
| TNM002 10 mg | Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002 | 1080000 h*ng/mL | Standard Deviation 384000 |
| TNM002 15 mg | Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002 | 1810000 h*ng/mL | Standard Deviation 499000 |
Secondary
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers)
The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.
Time frame: At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose
Population: The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TNM002 5 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | 24 hours | 0.0450 IU/mL |
| TNM002 5 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 30 | 0.1058 IU/mL |
| TNM002 5 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 21 | 0.1282 IU/mL |
| TNM002 5 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | 48 hours | 0.0687 IU/mL |
| TNM002 5 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 90 | 0.0189 IU/mL |
| TNM002 5 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 3 | 0.0957 IU/mL |
| TNM002 5 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 7 | 0.1264 IU/mL |
| TNM002 10 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 30 | 0.2119 IU/mL |
| TNM002 10 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 7 | 0.2655 IU/mL |
| TNM002 10 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 3 | 0.2057 IU/mL |
| TNM002 10 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 21 | 0.2563 IU/mL |
| TNM002 10 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 90 | 0.0381 IU/mL |
| TNM002 10 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | 48 hours | 0.1665 IU/mL |
| TNM002 10 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | 24 hours | 0.1095 IU/mL |
| TNM002 15 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 7 | 0.4786 IU/mL |
| TNM002 15 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | 24 hours | 0.2094 IU/mL |
| TNM002 15 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | 48 hours | 0.3007 IU/mL |
| TNM002 15 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 3 | 0.3835 IU/mL |
| TNM002 15 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 21 | 0.3898 IU/mL |
| TNM002 15 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 30 | 0.3217 IU/mL |
| TNM002 15 mg | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 90 | 0.0655 IU/mL |
| HTIG | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 3 | 0.0348 IU/mL |
| HTIG | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 90 | 0.0057 IU/mL |
| HTIG | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 30 | 0.0214 IU/mL |
| HTIG | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | 48 hours | 0.0295 IU/mL |
| HTIG | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | 24 hours | 0.0200 IU/mL |
| HTIG | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 21 | 0.0274 IU/mL |
| HTIG | Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers) | Day 7 | 0.0392 IU/mL |
Secondary
Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose
The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.
Time frame: Up to 105 (±7) days post dosing
Population: The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TNM002 5 mg | Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose | NA Day |
| TNM002 10 mg | Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose | NA Day |
| TNM002 15 mg | Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose | NA Day |
| HTIG | Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose | 59 Day |
Secondary
Elimination Half-life (t1/2) of TNM002
The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase.
Time frame: Up to 105 days post dosing
Population: Five participants were exlucded from the analysis due to model fitting failure for t1/2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TNM002 5 mg | Elimination Half-life (t1/2) of TNM002 | 586 hours |
| TNM002 10 mg | Elimination Half-life (t1/2) of TNM002 | 596 hours |
| TNM002 15 mg | Elimination Half-life (t1/2) of TNM002 | 661 hours |
Secondary
Maximum Concentration (Cmax) of TNM002
The peak serum concentration of TNM002 observed after administration.
Time frame: Up to 105 days post dosing
Population: All TNM002-treated participants had evaluable post-dose concentration data for the calculation of Cmax.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TNM002 5 mg | Maximum Concentration (Cmax) of TNM002 | 460 ng/mL | Geometric Coefficient of Variation 57.6 |
| TNM002 10 mg | Maximum Concentration (Cmax) of TNM002 | 967 ng/mL | Geometric Coefficient of Variation 52.6 |
| TNM002 15 mg | Maximum Concentration (Cmax) of TNM002 | 1710 ng/mL | Geometric Coefficient of Variation 34.5 |
Secondary
Positive Rate of ADA in Volunteers in TNM002 Groups
The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial.
Time frame: Up to 105 days post dosing
Population: All TNM002-treated participants had evaluable post-dose immunogenicity data for the ADA analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TNM002 5 mg | Positive Rate of ADA in Volunteers in TNM002 Groups | 3 Participants |
| TNM002 10 mg | Positive Rate of ADA in Volunteers in TNM002 Groups | 3 Participants |
| TNM002 15 mg | Positive Rate of ADA in Volunteers in TNM002 Groups | 1 Participants |
Secondary
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level
The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.
Time frame: At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose
Population: The analysis plan prespecified that placebo group data would not be collected for this outcome measure related to the anti-tetanus antibody level, as the administration of placebo precludes the generation of measurable antibody responses. Therefore, placebo recipients were analytically excluded from the efficacy analysis of antibody titer changes. The active control (HTIG) serves as the comparator for efficacy assessments, while the placebo group is retained solely for safety evaluations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNM002 5 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 48 hours | 58 Participants |
| TNM002 5 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 3 | 61 Participants |
| TNM002 5 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 7 | 61 Participants |
| TNM002 5 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 21 | 60 Participants |
| TNM002 5 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 30 | 59 Participants |
| TNM002 5 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 90 | 48 Participants |
| TNM002 10 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 90 | 58 Participants |
| TNM002 10 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 21 | 61 Participants |
| TNM002 10 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 48 hours | 61 Participants |
| TNM002 10 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 7 | 61 Participants |
| TNM002 10 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 3 | 61 Participants |
| TNM002 10 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 30 | 61 Participants |
| TNM002 15 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 3 | 29 Participants |
| TNM002 15 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 7 | 29 Participants |
| TNM002 15 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 21 | 29 Participants |
| TNM002 15 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 90 | 28 Participants |
| TNM002 15 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 30 | 29 Participants |
| TNM002 15 mg | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 48 hours | 29 Participants |
| HTIG | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 30 | 56 Participants |
| HTIG | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 90 | 18 Participants |
| HTIG | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 3 | 57 Participants |
| HTIG | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 21 | 57 Participants |
| HTIG | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | 48 hours | 55 Participants |
| HTIG | Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level | Day 7 | 59 Participants |
Secondary
Time to Maximum Concentration (Tmax) of TNM002
The time point at which the Cmax is observed following TNM002 administration.
Time frame: Up to 105 days post dosing
Population: All TNM002-treated participants had evaluable post-dose concentration data for the calculation of Tmax.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TNM002 5 mg | Time to Maximum Concentration (Tmax) of TNM002 | 312 hours |
| TNM002 10 mg | Time to Maximum Concentration (Tmax) of TNM002 | 311 hours |
| TNM002 15 mg | Time to Maximum Concentration (Tmax) of TNM002 | 144 hours |