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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNM002 | Experimental | If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002 |
|
| Human tetanus immunoglobulin (HTIG) | Active Comparator | If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM002 | Drug | Dosage Form: Injection, solution Route of administration: IM gluteal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level. | Baseline up to 12 hours after receipt of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Tetanus protection rate (1 - tetanus incidence) | Up to 28 days after receipt of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 105 days after receipt of study drug | |
| Incidence of treatment related adverse events (AEs) | Up to 105 days after receipt of study drug | |
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Chuanlin Wang, MD | Peking University People's Hospital | Principal Investigator |
| Shengyi Wang | Zhuhai Trinomab Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei First People's Hospital | Hefei | Anhui | 230061 | China | ||
| The Second Hospital of Anhui Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31795577 | Background | Wang CL, Liu S, Shao ZJ, Yin ZD, Chen QJ, Ma X, Ma C, Wang Q, Wang LH, Deng JK, Li YX, Zhao ZX, Wu D, Wu J, Zhang L, Yao KH, Gao Y, Xie X. [Guidelines for the use of post-traumatic tetanus vaccines and passive immune preparation]. Zhonghua Yu Fang Yi Xue Za Zhi. 2019 Dec 6;53(12):1212-1217. doi: 10.3760/cma.j.issn.0253-9624.2019.12.005. Chinese. | |
| 17854885 |
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Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).
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| Human tetanus immunoglobulin (HTIG) |
| Drug |
Dosage Form: Injection, solution Route of administration: IM gluteal injection |
|
| Incidence of serious adverse events (SAEs) |
| Up to 105 days after receipt of study drug |
| The number and percentage of subjects with abnormal hematology tests | The hemotology tests include red blood cell count, hemoglobin, platelet count, white blood cell count, absolute neutrophil count, neutrophil percentage, absolute lymphocyte count, lymphocytes percentage, absolute monocyte count, and hematocrit | Up to 90 days after receipt of study drug |
| The number and percentage of subjects with abnormal serum chemistry tests | The serum chemistry tests include total protein, albumin, sodium, potassium, chloride, calcium, glucose, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct bilirubin, urea (blood urea nitrogen) and creatinine | Up to 90 days after receipt of study drug |
| The number and percentage of subjects with abnormal urinalysis tests | The urinalysis tests include protein, glucose, urobilinogen, urine occult blood, red blood cell and white blood cell | Up to 90 days after receipt of study drug |
| The number and percentage of subjects with abnormal vital signs | The vital signs include blood pressure, pulse rate, respiratory rate, and body temperature | Up to 90 days after receipt of study drug |
| The number and percentage of subjects with abnormal physical examination | The physical examination includes skin, lymph nodes, eyes, head and neck, chest, abdomen, spine, extremities. | Up to 90 days after receipt of study drug |
| The number and percentage of subjects with abnormal 12-lead electrocardiogram (ECG) | Up to 90 days after receipt of study drug |
| Hefei |
| Anhui |
| 230601 |
| China |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510062 | China |
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
| The Third Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510150 | China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510180 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 511407 | China |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | 518025 | China |
| Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University | Liuzhou | Guangxi | 545007 | China |
| Affiliated Hospital of Zunyi Medical College | Zunyi | Guizhou | 563000 | China |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Hangzhou | 310014 | China |
| The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology | Wuhan | Hubei | 430014 | China |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430062 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| Affiliated Nanhua Hospital, University of South China | Hengyang | Hunan | 421010 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330008 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750003 | China |
| PKUCare Luzhong Hospital | Zibo | Shandong | 255499 | China |
| The First People's Hospital of Jinzhong | Jinzhong | Shanxi | 030602 | China |
| Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital) | Taiyuan | Shanxi | 030032 | China |
| Yuncheng Central Hospital - East Campus | Yuncheng | Shanxi | 044099 | China |
| Roper MH, Vandelaer JH, Gasse FL. Maternal and neonatal tetanus. Lancet. 2007 Dec 8;370(9603):1947-59. doi: 10.1016/S0140-6736(07)61261-6. |
| 28185446 | Background | Tetanus vaccines: WHO position paper - February 2017. Wkly Epidemiol Rec. 2017 Feb 10;92(6):53-76. No abstract available. English, French. |
| Background | Yu Chao, Xu Yuming, Xu Jin, et al. Progress of clinical application and safety of tetanus antitoxin. Chinese Journal of Pharmacovigilance, 2016, 13 (1): 36-41. |
| 5902706 | Background | Perey BJ. Progress in tetanus prophylaxis: the advent of human antitoxin. Can Med Assoc J. 1966 Feb 26;94(9):437-41. |
| Background | Plotkin, S.A., W.A. Orenstein and P.A. Offit, Plotkin's vaccines. Seventh edition. ed. 2018. 1691. |
| 29042200 | Background | Ortiz JR, Hombach J. Announcing the publication of the WHO immunological basis for immunization series module on influenza vaccines. Vaccine. 2018 Sep 5;36(37):5504-5505. doi: 10.1016/j.vaccine.2017.09.010. Epub 2017 Oct 16. |
| 9527776 | Background | Forrat R, Dumas R, Seiberling M, Merz M, Lutsch C, Lang J. Evaluation of the safety and pharmacokinetic profile of a new, pasteurized, human tetanus immunoglobulin administered as sham, postexposure prophylaxis of tetanus. Antimicrob Agents Chemother. 1998 Feb;42(2):298-305. doi: 10.1128/AAC.42.2.298. |
| 40628965 | Derived | Liang Z, Liu S, Guo W, Deng Z, Bin W, Yu A, Hu J, Wu L, Li Z, Huang W, Li H, Cheng D, Li S, Guo Q, Zhang D, Yan X, Wang C, Cai W, Ding B, Li W, Li X, Xu B, He L, Ouyang Y, Zhan H, Wang J, Zhao Y, Liu X, Xiang W, Zhang M, Zhang Z, Ding J, Kuang X, Zheng W, Liao H, Wang W, Wang C. Recombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial. Nat Med. 2025 Aug;31(8):2673-2681. doi: 10.1038/s41591-025-03791-8. Epub 2025 Jul 8. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 11, 2026 | Jul 9, 2026 | 6 |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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