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Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE1

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection in Healthy Participants

NCT07149454•Lanzhou Institute of Biological Products Co., Ltd

View on ClinicalTrials.gov

Summary

A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-tetanus toxin Monoclonal Antibody Injection in Healthy Participants.

Detailed Description

The primary objective of the study ： evaluate the safety and tolerability of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants. The secondary objectives are: 1. to evaluate the pharmacokinetic (PK) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants; 2. to evaluate the pharmacodynamic (PD) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants; 3. to evaluate the immunogenicity of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participants voluntarily agree to participate in the study and sign the informed consent form (ICF);
•2. Aged 18-60 years (inclusive) at the time of ICF signing, regardless of gender, with valid legal identification;
•3. Body weight ≥45.0 kg for female participants and ≥50.0 kg for male participants, with a body mass index (BMI) between 18.0 and 28.0 kg/m² (inclusive) (BMI = weight \[kg\]/height \[m²\]);
•4. Female participants of childbearing potential must have no plans for pregnancy or egg donation during the trial and for 6 months after investigational product administration and must voluntarily use at least one effective contraceptive method. Male participants must have no plans for pregnancy or sperm donation during the trial and for 6 months after investigational product administration, and either the male participant or his female partner of childbearing potential must voluntarily use at least one effective contraceptive method.

Exclusion Criteria

•1. Known allergy to the investigational product (including excipients or similar drugs), or documented hypersensitivity to essential materials used in the trial (e.g., skin disinfectants); or history of severe allergic diseases, hypersensitivity to monoclonal antibodies, or allergic constitution deemed by investigators to compromise participant safety;
•2. Acute/chronic medical conditions that may significantly affect drug metabolism or safety assessments per investigator judgment;
•3. History of autoimmune diseases or immunodeficiency disorders (including HIV-positive screening);
•4. Chronic hepatitis B/C (HBsAg or HCV antibody-positive during screening);
•5. History/family history of seizures, epilepsy, or neuropsychiatric disorders;
•6. Major surgery within 3 months (90 days) prior to dosing, or planned surgery during the trial;
•7. Prior tetanus infection or use of passive tetanus immunoglobulins within 6 months (180 days) before dosing;
•8. Tetanus-toxoid-containing vaccination (e.g., DTaP, Td, meningococcal conjugate vaccines) within 10 years;
•9. Positive tetanus IgG rapid test during screening;
•10. Receipt of live/inactivated vaccines within 1 month (30 days) before dosing or planned vaccination during the trial;
+13 more criteria

Locations (1)

Lanzhou Institute of Biological Products Co., Ltd.

Lanzhou, Gansu, China

Key Dates

Start Date

August 18, 2025

Primary Completion Date

May 27, 2026

Completion Date

June 24, 2026

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Tetanus

Interventions

Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

DRUG

Human Tetanus Immunoglobulin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

Inclusion Criteria

Exclusion Criteria

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

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A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)

Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand

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