Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

Sponsor

Trinomab Biotech Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05664750

Collaborator

(none)

675

Enrollment

Locations

Arms

7.8

Anticipated Duration (Months)

22.5

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Tetanus	Drug: TNM002 Drug: Human tetanus immunoglobulin (HTIG)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

675 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 22, 2022

Anticipated Primary Completion Date :

May 28, 2023

Anticipated Study Completion Date :

Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TNM002 If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002	Drug: TNM002 Dosage Form: Injection, solution Route of administration: IM gluteal injection
Active Comparator: Human tetanus immunoglobulin (HTIG) 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

Arm

Intervention/Treatment

Experimental: TNM002

If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002

Drug: TNM002

Dosage Form: Injection, solution Route of administration: IM gluteal injection

Active Comparator: Human tetanus immunoglobulin (HTIG)

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

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Tetanus protection rate (1 - tetanus incidence) [Up to 28 days after receipt of study drug]

Other Outcome Measures

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]
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 [Up to 90 days after receipt of study drug]
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
The number and percentage of subjects with abnormal serum chemistry tests [Up to 90 days after receipt of study drug]
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
The number and percentage of subjects with abnormal urinalysis tests [Up to 90 days after receipt of study drug]
The urinalysis tests include protein, glucose, urobilinogen, urine occult blood, red blood cell and white blood cell
The number and percentage of subjects with abnormal vital signs [Up to 90 days after receipt of study drug]
The vital signs include blood pressure, pulse rate, respiratory rate, and body temperature
The number and percentage of subjects with abnormal physical examination [Up to 90 days after receipt of study drug]
The physical examination includes skin, lymph nodes, eyes, head and neck, chest, abdomen, spine, extremities.
The number and percentage of subjects with abnormal 12-lead electrocardiogram (ECG) [Up to 90 days after receipt of study drug]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chinese male or female adults aged ≥ 18 years;
Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;
Participants who provide signed written informed consent form.

Exclusion Criteria:

Known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins;
Suspect or diagnosed as tetanus;
Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
Any clinically significant chronic or acute medical condition that makes the subject unsuitable for participation;
Current alcohol abuse, drug abuse or drug addiction

Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hefei First People's Hospital	Hefei	Anhui	China	230061
2	The Second Hospital of Anhui Medical University	Hefei	Anhui	China	230601
3	Beijing Tongren Hospital, CMU	Beijing	Beijing	China	100005
4	Peking University First Hospital	Beijing	Beijing	China	100034
5	Peking University People's Hospital	Beijing	Beijing	China	100044
6	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing	China	100070
7	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510062
8	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong	China	510120
9	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510150
10	Guangzhou First People's Hospital	Guangzhou	Guangdong	China	510180
11	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510515
12	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	511407
13	Shenzhen Second People's Hospital	Shenzhen	Guangdong	China	518025
14	Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University	Liuzhou	Guangxi	China	545007
15	Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou	China	563000
16	Hainan General Hospital	Haikou	Hainan	China	570311
17	Zhejiang Provincial People's Hospital	Hangzhou	Hangzhou	China	310014
18	The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology	Wuhan	Hubei	China	430014
19	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China	430030
20	Renmin Hospital of Wuhan University	Wuhan	Hubei	China	430060
21	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China	430062
22	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410011
23	Chenzhou NO.1 People's Hospital	Chenzhou	Hunan	China	423099
24	Affiliated Nanhua Hospital, University of South China	Hengyang	Hunan	China	421010
25	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330008
26	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	750003
27	PKUCare Luzhong Hospital	Zibo	Shandong	China	255499
28	The First People's Hospital of Jinzhong	Jinzhong	Shanxi	China	030602
29	Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)	Taiyuan	Shanxi	China	030032
30	Yuncheng Central Hospital - East Campus	Yuncheng	Shanxi	China	044099