TetanusPhase 2NCT05625477
Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers
A Phase 2 study testing TNM002 (low dose), TNM002 (medium dose) and TNM002 (high dose) in people with Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- TNM002 (low dose), TNM002 (medium dose) and TNM002 (high dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 4 sitesChina
- Study dates
- 18 Apr 2022to 18 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese male or female adults aged ≥ 18 years;
- Healthy volunteers or volunteers with stable chronic diseases;
- Volunteers who provide signed written informed consent form.
Who cannot join
- History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
- History of alcohol or other substance abuse.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong
Wuxi People's Hospital
Wuxi, Jiangsu
PKUCare Luzhong Hospital
Zibo, Shandong
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled, Dose-Finding Phase II Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo Following a Single Intramuscular Injection in Chinese Adult Volunteers
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.
- Conditions
- Tetanus
- Being tested
- TNM002 (low dose), TNM002 (medium dose), TNM002 (high dose), HTIG, Placebo
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM002 (low dose)Biological
Single dose of TNM002 administered by intramuscular injection
TNM002 (medium dose)Biological
Single dose of TNM002 administered by intramuscular injection
TNM002 (high dose)Biological
Single dose of TNM002 administered by intramuscular injection
HTIGBiological
Single dose of HTIG administered by intramuscular injection
PlaceboBiological
Single dose of placebo administered by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| TNM002 low dose | Experimental | Participants receive a single intramuscular injection of TNM002 with low dose on Day 1 Receives: Biological: TNM002 (low dose) |
| TNM002 medium dose | Experimental | Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1 Receives: Biological: TNM002 (medium dose) |
| TNM002 high dose | Experimental | Participants receive a single intramuscular injection of TNM002 with high dose on Day 1 Receives: Biological: TNM002 (high dose) |
| Human Tetanus Immunoglobulin (HTIG) | Active comparator | Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1 Receives: Biological: HTIG |
| Placebo | Placebo comparator | Participants receive a single intramuscular injection of placebo on Day 1 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24 hours post-dose
Secondary outcomes (9)
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.
Measured: At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose
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.
Measured: At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose
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.
Measured: Up to 105 (±7) days post dosing
Maximum Concentration (Cmax) of TNM002
The peak serum concentration of TNM002 observed after administration.
Measured: Up to 105 days post dosing
Time to Maximum Concentration (Tmax) of TNM002
The time point at which the Cmax is observed following TNM002 administration.
Measured: Up to 105 days post dosing
Elimination Half-life (t1/2) of TNM002
The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase.
Measured: Up to 105 days post dosing
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.
Measured: Up to 105 days post dosing
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.
Measured: Up to 105 days post dosing
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.
Measured: Up to 105 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start18 Apr 2022
- Primary completion29 May 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Hou, Principal investigator, Peking University Care Luzhong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625477
- Sponsor's protocol ID
- TNM002-P2-CH01
- Status last verified
- May 2023
- First submitted
- 11 Nov 2022
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Controlled, Dose-Finding Phase II Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo Following a Single Intramuscular Injection in Chinese Adult Volunteers
- ClinicalTrials.gov ID
- NCT05625477
- Acronym / sponsor ID
- TNM002-P2-CH01
- Conditions
- Tetanus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Posted 16 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TNM002 low dose | Experimental | Biological: TNM002 (low dose)Participants receive a single intramuscular injection of TNM002 with low dose on Day 1 |
| TNM002 medium dose | Experimental | Biological: TNM002 (medium dose)Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1 |
| TNM002 high dose | Experimental | Biological: TNM002 (high dose)Participants receive a single intramuscular injection of TNM002 with high dose on Day 1 |
| Human Tetanus Immunoglobulin (HTIG) | Active comparator | Biological: HTIGParticipants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1 |
| Placebo | Placebo comparator | Biological: PlaceboParticipants receive a single intramuscular injection of placebo on Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese male or female adults aged ≥ 18 years;
- Healthy volunteers or volunteers with stable chronic diseases;
- Volunteers who provide signed written informed consent form.
Key exclusion criteria (3 listed)
- History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
- History of alcohol or other substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNM002 (low dose)Single dose of TNM002 administered by intramuscular injection | Biological | TNM002 low dose |
| TNM002 (medium dose)Single dose of TNM002 administered by intramuscular injection | Biological | TNM002 medium dose |
| TNM002 (high dose)Single dose of TNM002 administered by intramuscular injection | Biological | TNM002 high dose |
| HTIGSingle dose of HTIG administered by intramuscular injection | Biological | Human Tetanus Immunoglobulin (HTIG) |
| PlaceboSingle dose of placebo administered by intramuscular injection | Biological | Placebo |
Primary outcome
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level
Time frame: 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.
9 secondary outcomes
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers)
Time frame: At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level
Time frame: At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose
Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose
Time frame: Up to 105 (±7) days post dosing
Maximum Concentration (Cmax) of TNM002
Time frame: Up to 105 days post dosing
Time to Maximum Concentration (Tmax) of TNM002
Time frame: Up to 105 days post dosing
Elimination Half-life (t1/2) of TNM002
Time frame: Up to 105 days post dosing
Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002
Time frame: Up to 105 days post dosing
Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002
Time frame: Up to 105 days post dosing
Positive Rate of ADA in Volunteers in TNM002 Groups
Time frame: Up to 105 days post dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Hou principal investigator
Peking University Care Luzhong Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNM002 (low dose), TNM002 (medium dose) and TNM002 (high dose) in people with Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level (time frame: At 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.