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

NCT05664750 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Tetanus

Interventions

DRUG

TNM002

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

DRUG

Human tetanus immunoglobulin (HTIG)

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

Sponsors & Collaborators

  • Zhuhai Trinomab Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chuanlin Wang, MD · Peking University People's Hospital

  • Shengyi Wang · Zhuhai Trinomab Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2023-03-24
Completion
2023-07-07
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664750 on ClinicalTrials.gov