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

NCT07149454 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: LIBP-TAB-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tetanus

Keywords

Tetanus Antitoxin

Outcome Measures

Primary Outcomes (12)

• The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit

  Types of Adverse Events / Serious Adverse Reactions

  105 days

• The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit

  Incidence of Adverse Events/Serious Adverse Reactions

  105Days

• The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit

  Severity of Adverse Events (AEs)/Serious Adverse Reactions (SARs)

  105Days

• The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit

  Relationship of Adverse Events (AEs)/Serious Adverse Reactions (SARs) to the Investigational Product

  105Days

• The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.

  12-lead electrocardiogram examination：P Wave

  105Days

• The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.

  12-lead electrocardiogram examination：QRS Complex

  105Days

• The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.

  12-lead electrocardiogram examination：T Wave

  105Days

• The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.

  12-lead electrocardiogram examination：U Wave

  105Days

• The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.

  12-lead electrocardiogram examination：PR Interval

  105Days

• The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.

  12-lead electrocardiogram examination：QT Interval

  105Days

• The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.

  12-lead electrocardiogram examination：ST Segment

  105Days

• Clinically significant changes in laboratory parameters from baseline at specified timepoints post-dosing

  Complete Blood Count (CBC)

  105Days

Secondary Outcomes (15)

• Pharmacokinetic Endpoints

  105Days

• Pharmacokinetic Endpoints

  105Days

• Pharmacokinetic Endpoints

  105Days

• Pharmacokinetic Endpoints

  105Days

• Pharmacokinetic Endpoints

  105Days

Study Arms (5)

Group 1 (0.2 mg dose group)

EXPERIMENTAL

A single dose was administered to 3 enrolled participants, who were randomized in a 2:1 ratio to receive either the recombinant human anti-tetanus toxin monoclonal antibody injection or placebo. After all participants completed the 14-day safety observation period and were evaluated as safe and tolerable, administration for the next dose group could proceed.

Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection; Drug: Placebo

Group 2 (2 mg dose group)

EXPERIMENTAL

A single dose was administered to 8 enrolled participants, who were randomized in a 3:1 ratio to receive either the recombinant human anti-tetanus toxin monoclonal antibody injection or placebo. After all participants completed the 14-day safety observation period for the current dose group and were evaluated as safe and tolerable, the trial proceeded to the next dose group.

Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection; Drug: Placebo

Group 3 (5 mg dose group)

EXPERIMENTAL

A single dose was administered to 15 enrolled participants, who were randomized in a 4:1 ratio to receive either the recombinant human anti-tetanus toxin monoclonal antibody injection or placebo. After all participants completed the 14-day safety observation period for the current dose group and were evaluated as safe and tolerable, the study proceeded to the next cohort.

Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection; Drug: Placebo

Group 4 (10 mg dose group)

EXPERIMENTAL

A single dose was administered to 27 enrolled participants, who were randomized in a 4:4:1 ratio to receive either: the recombinant human anti-tetanus toxin monoclonal antibody injection, human tetanus immunoglobulin (HTIG) injection, or placebo. After all participants completed the 14-day safety observation period for the current dose group and were evaluated as safe and tolerable, the study advanced to the next phase.

Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection; Drug: Human Tetanus Immunoglobulin; Drug: Placebo

Group 5 (15 mg dose group)

EXPERIMENTAL

A single dose was administered to 15 enrolled participants who were randomized in a 4:1 ratio to receive either the recombinant human anti-tetanus toxin monoclonal antibody injection or placebo. As this represented the highest planned dose level, the sponsor and investigators jointly determined whether to continue dose escalation based on the absence of tolerability concerns.

Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection; Drug: Placebo

Interventions

Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection DRUG

intramuscular injection

Group 1 (0.2 mg dose group); Group 2 (2 mg dose group); Group 3 (5 mg dose group); Group 4 (10 mg dose group); Group 5 (15 mg dose group)

Human Tetanus Immunoglobulin DRUG

intramuscular injection

Group 4 (10 mg dose group)

Placebo DRUG

intramuscular injection

Group 1 (0.2 mg dose group); Group 2 (2 mg dose group); Group 3 (5 mg dose group); Group 4 (10 mg dose group); Group 5 (15 mg dose group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants voluntarily agree to participate in the study and sign the informed consent form (ICF);
• Aged 18-60 years (inclusive) at the time of ICF signing, regardless of gender, with valid legal identification;
• 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 \[m²\]);
• 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.

You may not qualify if:

• 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;
• Acute/chronic medical conditions that may significantly affect drug metabolism or safety assessments per investigator judgment;
• History of autoimmune diseases or immunodeficiency disorders (including HIV-positive screening);
• Chronic hepatitis B/C (HBsAg or HCV antibody-positive during screening);
• History/family history of seizures, epilepsy, or neuropsychiatric disorders;
• Major surgery within 3 months (90 days) prior to dosing, or planned surgery during the trial;
• Prior tetanus infection or use of passive tetanus immunoglobulins within 6 months (180 days) before dosing;
• Tetanus-toxoid-containing vaccination (e.g., DTaP, Td, meningococcal conjugate vaccines) within 10 years;
• Positive tetanus IgG rapid test during screening;
• Receipt of live/inactivated vaccines within 1 month (30 days) before dosing or planned vaccination during the trial;
• Systemic corticosteroids/immunosuppressants within 3 months (90 days) (excluding inhaled/topical use);
• Prescription/OTC/herbal medications within 14 days or \<5 half-lives (whichever is longer) prior to dosing, particularly those interfering with the investigational monoclonal antibody's PK/safety (per criterion #11 for exceptions);
• Participation in other clinical trials involving investigational drugs/devices within 3 months (90 days) or planned concurrent enrollment;
• Excessive alcohol intake (\>14 units/week; 1 unit = 360 mL beer/45 mL 40% liquor/150 mL wine), alcohol use within 48 hours pre-dose, or positive breathalyzer test;
• Heavy smoking (\>10 cigarettes/day or equivalent) within 1 month (30 days);

Sponsors & Collaborators

• Lanzhou Institute of Biological Products Co., Ltd: lead

Study Sites (1)

Lanzhou Institute of Biological Products Co., Ltd.

Lanzhou, Gansu, 730000, China

Location

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jianchang He

  Yunnan Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: September 2, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-08

Locations

CN (1)