A Phase 1 interventional study of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection and Human Tetanus Immunoglobulin in Tetanus, sponsored by Lanzhou Institute of Biological Products Co., Ltd. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Lanzhou Institute of Biological Products Co., Ltd (part of Sinopharm) · Phase 1, Interventional, and Treatment
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.
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:
318 studies on the registry are indexed under Tetanus; 29 are open to participants now.
This study's planned enrollment of 68 is below the median of 418 across 280 interventional studies indexed under Tetanus.
Browse Tetanus studies →Lanzhou Institute of Biological Products Co., Ltd is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
First submitted after Lanzhou Institute of Biological Products Co., Ltd became part of Sinopharm.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
intramuscular injection
intramuscular injection
intramuscular injection
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 105Days
Clinically significant changes in laboratory parameters from baseline at specified timepoints post-dosing
Complete Blood Count (CBC)
Time frame: 105Days
Pharmacokinetic Endpoints
Cmax: Maximum plasma concentration
Time frame: 105Days
Pharmacokinetic Endpoints
AUC\~0-t: Area under the curve from 0 to last measurable timepoint
Time frame: 105Days
Pharmacokinetic Endpoints
AUC\~0-∞: Area under the curve extrapolated to infinity
Time frame: 105Days
Pharmacokinetic Endpoints
T\~max: Time to reach Cmax
Time frame: 105Days
Pharmacokinetic Endpoints
t\~1/2: Elimination half-life
Time frame: 105Days
Pharmacokinetic Endpoints
CL/F: Apparent clearance
Time frame: 105Days
Pharmacokinetic Endpoints
Vz/F：Apparent Volume of Distribution during Terminal Phase
Time frame: 105Days
Pharmacokinetic Endpoints
MRT：Mean Residence Time
Time frame: 105Days
Pharmacodynamic Endpoints
Change in tetanus-neutralizing antibody titer from baseline within 12 hours post-dose across treatment groups
Time frame: 0 to 12 hours
Pharmacodynamic Endpoints
Percentage of participants with anti-tetanus toxin neutralizing antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at each timepoint post-dose across treatment groups
Time frame: 105Days
Pharmacodynamic Endpoints
Percentage of participants with anti-tetanus toxin neutralizing antibody titer increases from baseline ≥0.01 IU/mL and ≥0.1 IU/mL at each timepoint post-dose across treatment groups
Time frame: 105Days
Exposure-Response Analysis, E-R Analysis
Exposure-response (E-R) analysis of serum drug concentrations versus anti-tetanus toxin neutralizing antibody titers at each post-dose timepoint across treatment groups
Time frame: 105Days
Immunogenicity Endpoints
Anti-drug antibody (ADA) titers against the investigational drug (recombinant human anti-tetanus toxin monoclonal antibody) in serum at each post-dose timepoint across treatment groups
Time frame: 105Days
Immunogenicity Endpoints
Incidence of anti-drug antibodies (ADA) against the investigational drug (recombinant human anti-tetanus toxin monoclonal antibody) in serum post-dose across treatment groups
Time frame: 105Days
Immunogenicity Endpoints
In participants who tested positive for anti-drug antibodies (ADA), the incidence of neutralizing antibodies (NAb) was assessed.
Time frame: 105Days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for May 2026, 9 months after the start.
How these figures are worked out, and which studies are left out of them.
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Lanzhou Institute of Biological Products Co., Ltd →