A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Phase III Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

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.

Start Date22 Dec 2022

Sponsor / Collaborator

Trinomab Biotech Co., Ltd

CTR20223067 / CompletedPhase 3

一项比较TNM002注射液和破伤风人免疫球蛋白被动免疫预防破伤风感染的有效性和安全性的多中心、随机、双盲、平行、阳性对照III期临床试验

[Translation] A multicenter, randomized, double-blind, parallel, positive-controlled phase III clinical trial comparing the efficacy and safety of TNM002 injection and tetanus human immunoglobulin in passive immunization for preventing tetanus infection

主要目的：比较TNM002注射液与破伤风人免疫球蛋白（HTIG）单次肌肉注射预防破伤风感染的有效性。次要有效性研究目的：比较TNM002注射液与HTIG单次肌肉注射预防破伤风感染后相关临床结局。安全性研究目的：比较TNM002注射液与HTIG单次肌肉注射预防破伤风感染的安全性。

[Translation]

Primary purpose: To compare the effectiveness of a single intramuscular injection of TNM002 injection and tetanus human immunoglobulin (HTIG) in preventing tetanus infection. Secondary effectiveness study purpose: To compare the clinical outcomes related to a single intramuscular injection of TNM002 injection and HTIG in preventing tetanus infection. Safety study purpose: To compare the safety of a single intramuscular injection of TNM002 injection and HTIG in preventing tetanus infection.

Start Date22 Dec 2022

Sponsor / Collaborator

Trinomab Biotech Co., Ltd

CTR20222552 / CompletedPhase 1

一项在中国健康受试者中进行的TNM002与吸附破伤风疫苗单独给药和联合给药的随机、开放、平行设计的药代动力学和药效学相互作用研究

[Translation] A randomized, open-label, parallel-design pharmacokinetic and pharmacodynamic interaction study of TNM002 and adsorbed tetanus vaccine alone and in combination in healthy Chinese subjects

主要目的是健康成年受试者中，评估TNM002与吸附破伤风疫苗联用后对TNM002药代动力学（PK）和药效学（PD）特征的影响；健康成年受试者中，评估TNM002与吸附破伤风疫苗联用后对吸附破伤风疫苗PD特征的影响。次要目的是健康成年受试者中，评估TNM002与吸附破伤风疫苗单独给药或联用后的安全性和耐受性；健康成年受试者中，评估TNM002与吸附破伤风疫苗联用后对TNM002免疫原性的影响。

[Translation]

The primary objective is to evaluate the effect of TNM002 combined with adsorbed tetanus vaccine on the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of TNM002 in healthy adult subjects; to evaluate the effect of TNM002 combined with adsorbed tetanus vaccine on the PD characteristics of adsorbed tetanus vaccine in healthy adult subjects. The secondary objective is to evaluate the safety and tolerability of TNM002 and adsorbed tetanus vaccine alone or in combination in healthy adult subjects; to evaluate the effect of TNM002 combined with adsorbed tetanus vaccine on the immunogenicity of TNM002 in healthy adult subjects.

Start Date17 Oct 2022

Sponsor / Collaborator

Trinomab Biotech Co., Ltd

100 Clinical Results associated with Siltartoxatug

100 Translational Medicine associated with Siltartoxatug

100 Patents (Medical) associated with Siltartoxatug

100 Deals associated with Siltartoxatug

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Indication	Highest Phase	Country/Location	Organization	Date
Tetanus	NDA/BLA	CN	Trinomab Biotech Co., Ltd	06 Dec 2023

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