CompletedNCT05625477Updated Sep 16, 2025Results posted

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 interventional study of TNM002 (low dose) and TNM002 (medium dose) in Tetanus, sponsored by Zhuhai Trinomab Pharmaceutical Co., Ltd.. Completed at 4 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Zhuhai Trinomab Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Prevention

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Apr 2022, registered Nov 2022).

Phase: Phase 2
Study type: Interventional
Enrollment: 240
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Tetanus

Browse trials for

Tetanus 318

In context

Tetanus

318 studies on the registry are indexed under Tetanus; 29 are open to participants now.

This study's enrollment of 240 is below the median of 418 across 280 interventional studies indexed under Tetanus.

Browse Tetanus studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Chinese male or female adults aged ≥ 18 years;
Healthy volunteers or volunteers with stable chronic diseases;
Volunteers who provide signed written form.

Exclusion criteria

Exclusion Criteria:

History of allergy to the product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
Any chronic or acute medical condition that makes the volunteer unsuitable for participation;
History of alcohol or other substance abuse.

Terms in these criteria, in plain language(3)

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.

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.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 240 participants (actual)

Study arms

Experimental
TNM002 low dose
Participants receive a single intramuscular injection of TNM002 with low dose on Day 1
Biological: TNM002 (low dose)
Experimental
TNM002 medium dose
Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1
Biological: TNM002 (medium dose)
Experimental
TNM002 high dose
Participants receive a single intramuscular injection of TNM002 with high dose on Day 1
Biological: TNM002 (high dose)
Active comparator
Human Tetanus Immunoglobulin (HTIG)
Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1
Biological: HTIG
Placebo comparator
Placebo
Participants receive a single intramuscular injection of placebo on Day 1
Biological: Placebo

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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
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
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
Maximum Concentration (Cmax) of TNM002
The peak serum concentration of TNM002 observed after administration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 105 days post dosing

Results

Posted Sep 16, 2025

Participant flow

A total of 240 adult participants were recruited from 4 study sites in China, from 18 April 2022 to 27 May 2022.

Participant flow — Overall Study
Milestone	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo
Started	61	61	29	59	30
Completed	58	59	28	58	30
Not completed	3	2	1	1	0
Withdrew: Lost to follow-up	2	2	1	1	0
Withdrew: Covid quarantine	1	0	0	0	0

Outcome measures

PrimaryProportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level

Time frame:: At 24 hours post-dose
Reported as:: Count of participants · Participants

Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level
Participants	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level	56	61	29	48	0

SecondaryChange 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
Reported as:: Geometric mean · IU/mL

Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers)
IU/mL	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo
24 hours	0.0450 (0.0338 to 0.0597)	0.1095 (0.0844 to 0.1418)	0.2094 (0.1637 to 0.2677)	0.0200 (0.0158 to 0.0253)	—
48 hours	0.0687 (0.0529 to 0.0889)	0.1665 (0.1338 to 0.2071)	0.3007 (0.2446 to 0.3695)	0.0295 (0.0240 to 0.0362)	—
Day 3	0.0957 (0.0771 to 0.1188)	0.2057 (0.1691 to 0.2503)	0.3835 (0.3201 to 0.4593)	0.0348 (0.0288 to 0.0419)	—
Day 7	0.1264 (0.1057 to 0.1511)	0.2655 (0.2288 to 0.3081)	0.4786 (0.4126 to 0.5551)	0.0392 (0.0336 to 0.0456)	—
Day 21	0.1282 (0.1154 to 0.1425)	0.2563 (0.2357 to 0.2788)	0.3898 (0.3549 to 0.4280)	0.0274 (0.0230 to 0.0327)	—
Day 30	0.1058 (0.0959 to 0.1166)	0.2119 (0.1946 to 0.2306)	0.3217 (0.2943 to 0.3518)	0.0214 (0.0187 to 0.0243)	—
Day 90	0.0189 (0.0160 to 0.0223)	0.0381 (0.0338 to 0.0430)	0.0655 (0.0546 to 0.0785)	0.0057 (0.0039 to 0.0080)	—

SecondaryProportion 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
Reported as:: Count of participants · Participants

Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level
Participants	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo
48 hours	58	61	29	55	—
Day 3	61	61	29	57	—
Day 7	61	61	29	59	—
Day 21	60	61	29	57	—
Day 30	59	61	29	56	—
Day 90	48	58	28	18	—

SecondaryDuration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose

Time frame:: Up to 105 (±7) days post dosing
Reported as:: Median · Day

Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose
Day	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo
Duration of Anti-tetanus Neutralizing Antibody Titers Increasing From Baseline Over Protective Level Post-dose	NA (2 to 112)	NA (58 to 111)	NA (31 to 108)	59 (9 to 106)	—

SecondaryMaximum Concentration (Cmax) of TNM002

The peak serum concentration of TNM002 observed after administration.

Time frame:: Up to 105 days post dosing
Reported as:: Geometric mean · ng/mL

Maximum Concentration (Cmax) of TNM002
ng/mL	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg
Maximum Concentration (Cmax) of TNM002	460 ± 57.6	967 ± 52.6	1710 ± 34.5

SecondaryTime 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
Reported as:: Median · hours

Time to Maximum Concentration (Tmax) of TNM002
hours	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg
Time to Maximum Concentration (Tmax) of TNM002	312 (72 to 698)	311 (72 to 698)	144 (72 to 481)

SecondaryElimination 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
Reported as:: Median · hours

Elimination Half-life (t1/2) of TNM002
hours	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg
Elimination Half-life (t1/2) of TNM002	586 (415 to 988)	596 (353 to 991)	661 (416 to 867)

SecondaryArea 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
Reported as:: Mean · h*ng/mL

Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002
h*ng/mL	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg
Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002	524000 ± 231000	1080000 ± 384000	1810000 ± 499000

SecondaryArea 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
Reported as:: Mean · h*ng/mL

Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002
h*ng/mL	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg
Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002	589000 ± 244000	1180000 ± 416000	1990000 ± 559000

SecondaryPositive 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
Reported as:: Count of participants · Participants

Positive Rate of ADA in Volunteers in TNM002 Groups
Participants	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg
Positive Rate of ADA in Volunteers in TNM002 Groups	3	3	1

Adverse events

Collected over From enrollment until end of follow-up, up to 105 (±7) days post dosing. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
TNM002 5 mg	0/61 (0%)	0/61 (0%)	30/61 (49.2%)
TNM002 10 mg	0/61 (0%)	0/61 (0%)	29/61 (47.5%)
TNM002 15 mg	0/29 (0%)	0/29 (0%)	14/29 (48.3%)
HTIG	0/59 (0%)	1/59 (1.7%)	32/59 (54.2%)
Placebo	0/30 (0%)	0/30 (0%)	16/30 (53.3%)

Most frequent serious events

Most frequent serious events
Event	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo
Subdural hemorrhageNervous system disorders	0/61	0/61	0/29	1/59	0/30

Most frequent other events

Showing 10 of 22

Most frequent other events
Event	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo
Blood triglycerides increasedInvestigations	6/61	8/61	2/29	3/59	5/30
Alanine aminotransferaseInvestigations	2/61	1/61	2/29	2/59	4/30
Blood uric acid increasedInvestigations	6/61	7/61	0/29	4/59	2/30
Bilirubin conjugated increasedInvestigations	1/61	4/61	0/29	4/59	0/30
Neutrophil count decreasedInvestigations	2/61	2/61	0/29	1/59	2/30
Upper respiratory tract infectionInfections and infestations	4/61	1/61	0/29	1/59	2/30
Blood magnesium decreasedInvestigations	0/61	1/61	0/29	2/59	2/30
Gamma-glutamyltransferase increasedInvestigations	2/61	0/61	0/29	1/59	2/30
Monocyte count increasedInvestigations	1/61	2/61	1/29	3/59	0/30
Neutrophil count increasedInvestigations	2/61	1/61	0/29	3/59	1/30

Baseline characteristics

Age, Continuous
Age, Continuous(years of age)	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo	Total
Median	40 (20 to 62)	38 (22 to 59)	33 (22 to 62)	36 (20 to 63)	38.5 (19 to 60)	38 (19 to 63)

Sex: Female, Male
Sex: Female, Male(Participants)	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo	Total
Female	20	21	8	26	13	88
Male	41	40	21	33	17	152

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo	Total
Count of participants	—	—	—	—	—	0

Anti-tetanus neutralizing antibody titers
Anti-tetanus neutralizing antibody titers(IU/mL)	TNM002 5 mg	TNM002 10 mg	TNM002 15 mg	HTIG	Placebo	Total
Geometric mean	0.4982 ± 2.1697	0.0916 ± 0.3253	0.0362 ± 0.0583	0.0596 ± 0.2530	0.0738 ± 0.2194	0.1782 ± 1.125

Study locations

4 sites

The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
PKUCare Luzhong Hospital
Zibo, Shandong, China
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Jun 20, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in May 2022, 1 month.

Results were first posted in Sep 2025, 3 years 3 months after primary completion. A results delay was requested in May 2023.

Of 11 phase 2 interventional studies under Tetanus, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 17. This study's 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 11, 2022
First posted: Nov 23, 2022
StartActual: Apr 18, 2022
Primary completionActual: May 29, 2022
CompletionActual: Oct 18, 2022
Results delay requested: May 18, 2023
Results first posted: Sep 16, 2025
Last update: Sep 16, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05625477
Lead sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Nov 23, 2022
Start date: Apr 18, 2022
Primary completion: May 29, 2022
Completion: Oct 18, 2022
Results posted: Sep 16, 2025
Last update: Sep 16, 2025

Study contacts

Jie Hou

principal investigator · Peking University Care Luzhong Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Siltartoxatug

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Zhuhai Trinomab Pharmaceutical Co., Ltd.

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