A Phase 3 interventional study of TNM002 and Human tetanus immunoglobulin (HTIG) in Tetanus, sponsored by Zhuhai Trinomab Pharmaceutical Co., Ltd.. Completed at 28 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Zhuhai Trinomab Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.
318 studies on the registry are indexed under Tetanus; 29 are open to participants now.
This study's enrollment of 675 is above the median of 418 across 280 interventional studies indexed under Tetanus.
Browse Tetanus studies →Zhuhai Trinomab Pharmaceutical Co., Ltd. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002
Drug: TNM002
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
Drug: Human tetanus immunoglobulin (HTIG)
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose
The change of anti-tetanus neutralizing antibody titers from baseline 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: Baseline up to 12 hours after receipt of study drug
Tetanus Protection Rate on Day 28 Post-dose
The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame.
Time frame: Up to 28 days after receipt of study drug
Percentage of Participants With ΔTiters ≥0.01 IU/mL on Days 3, 7, 28, and 90 Post-dose.
The change of anti-tetanus neutralizing antibody titers from baseline 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: Up to 90 days after receipt of study drug
∆Titers at 12 Hours, and on Days 3, 7, 28 and 90 Post-dose
The change 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 12 hours, and on Days 3, 7, 28 and 90 post-dose
Tetanus Protection Rate on Days 90 and 105 Post-dose
The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame.
Time frame: Up to 105 days after receipt of study drug
TNM002 Serum Concentration
Arithmetic mean concentrations of TNM002 at each specified timepoint
Time frame: pre-dose, 12h, and Days 3, 7, 28, 90 post-dose
Anti-drug Antibodies (ADA) Against TNM002
The positive rate of ADA in the TNM002 group at each specified timepoint
Time frame: pre-dose, and Days 7, 28, and 90 post-dose
A total of 675 adult participants were recruited from 22 December 2022 to 23 March 2023.
| Milestone | TNM002 | HTIG |
|---|---|---|
| Started | 450 | 225 |
| Participants treated | 440 | 221 |
| Completed | 434 | 215 |
| Not completed | 16 | 10 |
| Withdrew: Withdrawal by subject | 14 | 6 |
| Withdrew: Protocol violation | 1 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 |
The change of anti-tetanus neutralizing antibody titers from baseline 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.
| Participants | TNM002 | HTIG |
|---|---|---|
| Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose | 418 | 117 |
The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame.
| Participants | TNM002 | HTIG |
|---|---|---|
| Tetanus Protection Rate on Day 28 Post-dose | 437 | 219 |
The change of anti-tetanus neutralizing antibody titers from baseline 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.
| Participants | TNM002 | HTIG |
|---|---|---|
| Day 3 | 388 | 187 |
| Day 7 | 388 | 190 |
| Day 28 | 387 | 184 |
| Day 90 | 353 | 19 |
The change 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.
| IU/mL | TNM002 | HTIG |
|---|---|---|
| 12 hours | 0.0602 (0.0546 to 0.0663) | 0.0100 (0.00883 to 0.0114) |
| Day 3 | 0.187 (0.174 to 0.201) | 0.0332 (0.0304 to 0.0363) |
| Day 7 | 0.233 (0.220 to 0.247) | 0.0360 (0.0335 to 0.0386) |
| Day 28 | 0.156 (0.150 to 0.163) | 0.0208 (0.0192 to 0.0225) |
| Day 90 | 0.0253 (0.0236 to 0.0272) | 0.00429 (0.00369 to 0.00495) |
The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame.
| Participants | TNM002 | HTIG |
|---|---|---|
| Day 90 | 437 | 217 |
| Day 105 | 432 | 214 |
Arithmetic mean concentrations of TNM002 at each specified timepoint
| ng/mL | TNM002 |
|---|---|
| pre-dose | 0 ± 15.0 |
| 12 hours | 298 ± 264 |
| Day 3 | 768 ± 434 |
| Day 7 | 897 ± 373 |
| Day 28 | 620 ± 229 |
| Day 90 | 109 ± 71.3 |
The positive rate of ADA in the TNM002 group at each specified timepoint
| Participants | TNM002 |
|---|---|
| Baseline | 8 |
| Day 7 | 8 |
| Day 28 | 31 |
| Day 90 | 50 |
Collected over From enrollment until end of follow-up, up to 105 (±7) days post-dose. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TNM002 | 0/440 (0%) | 6/440 (1.4%) | 131/440 (29.8%) |
| HTIG | 1/221 (0.5%) | 2/221 (0.9%) | 49/221 (22.2%) |
| Event | TNM002 | HTIG |
|---|---|---|
| Gastric haemorrhageGastrointestinal disorders | 0/440 | 1/221 |
| DeathGeneral disorders | 0/440 | 1/221 |
| AnaemiaBlood and lymphatic system disorders | 0/440 | 1/221 |
| Anal fistulaGastrointestinal disorders | 1/440 | 0/221 |
| HaemorrhoidsGastrointestinal disorders | 1/440 | 0/221 |
| Large intestine polypGastrointestinal disorders | 1/440 | 0/221 |
| Ventricular extrasystolesCardiac disorders | 1/440 | 0/221 |
| Anal abscessInfections and infestations | 1/440 | 0/221 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/440 | 0/221 |
| Event | TNM002 | HTIG |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 41/440 | 10/221 |
| Urinary tract infectionInfections and infestations | 15/440 | 10/221 |
| Covid-19Infections and infestations | 11/440 | 3/221 |
| CoughRespiratory, thoracic and mediastinal disorders | 10/440 | 5/221 |
| DizzinessNervous system disorders | 5/440 | 5/221 |
| AnaemiaBlood and lymphatic system disorders | 4/440 | 4/221 |
| BronchitisInfections and infestations | 7/440 | 1/221 |
| Urinary occult blood positiveInvestigations | 7/440 | 3/221 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 7/440 | 1/221 |
| Gamma-glutamyltransferase increasedInvestigations | 6/440 | 1/221 |
There were 14 participants (TNM002 group: 10; HTIG gtoup: 4) who were assigned to study arms but not treated. The number of baseline participants are the number of participants who were actually treated.
| Age, Continuous(years) | TNM002 | HTIG | Total |
|---|---|---|---|
| Mean | 43.2 ± 12.17 | 42.5 ± 12.93 | 42.9 ± 12.43 |
| Age, Customized(Participants) | TNM002 | HTIG | Total |
|---|---|---|---|
| Age, categorical — ≤65 years | 430 | 214 | 644 |
| Age, categorical — > 65 to ≤ 75 years | 9 | 6 | 15 |
| Age, categorical — > 75 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | TNM002 | HTIG | Total |
|---|---|---|---|
| Female | 185 | 88 | 273 |
| Male | 255 | 133 | 388 |
| Race/Ethnicity, Customized(Participants) | TNM002 | HTIG | Total |
|---|---|---|---|
| Ethnicity — Han Chinese | 425 | 210 | 635 |
| Ethnicity — Other | 15 | 11 | 26 |
| Baseline anti-tetanus antibody titers(IU/mL) | TNM002 | HTIG | Total |
|---|---|---|---|
| Geometric mean | 0.00729 (0 to 3.82) | 0.00812 (0 to 0.648) | 0.00756 (0 to 3.82) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Deidentified individual participant data are available under restricted access. Trinomab will assess all requests for additional data sharing. Requests should be sent to Trinomab with a detailed proposal outlining the intended use and the responses can be expected within one month. A signed data access agreement with Trinomab is required prior to data sharing.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Siltartoxatug
Zhuhai Trinomab Pharmaceutical Co., Ltd.