By InvitationPhase 1

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

China68 participantsStarted 2025-08-18

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 105 days

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

Timeframe: 105Days

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

Timeframe: 105Days

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

Timeframe: 105Days

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

Timeframe: 105Days

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

Timeframe: 105Days

Trial details

NCT IDNCT07149454

SponsorLanzhou Institute of Biological Products Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-27

View on ClinicalTrials.gov More Tetanus trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

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

Timeframe: 105 days

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

Timeframe: 105Days

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

Timeframe: 105Days

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

Timeframe: 105Days

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

Timeframe: 105Days

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

Timeframe: 105Days