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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation

NCT06360250 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-04-11

No results posted yet for this study

Summary

To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation

Conditions

  • Clostridium Tetanus

Interventions

DRUG

Human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination preparation

Each dose (1.0 ml) contained 1.25 mg of human anti-tetanus toxin monoclonal antibody A82 and 1.25 mg of human anti-tetanus toxin monoclonal antibody B86.

DRUG

Tetanus human immunoglobulin (HTIG)

Tetanus human immunoglobulin (HTIG)

DRUG

Whole-human anti-tetanus toxin monoclonal antibody A82 / B86 injection placebo

There were no active ingredients, and other ingredients were the same

BIOLOGICAL

Adsorbed tetanus vaccine (TT)

containing tetanus toxoid titer not less than 40 IU

Sponsors & Collaborators

  • The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Anning City First People's Hospital

    collaborator UNKNOWN

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2024-10-30
Completion
2024-10-30

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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 NCT06360250 on ClinicalTrials.gov