TetanusPhase 1NCT07149454
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection
A Phase 1 study testing Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection and Human Tetanus Immunoglobulin in people with Tetanus, run by Lanzhou Institute of Biological Products Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection and Human Tetanus Immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2025to 24 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 23Show fewer
- 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);
- Blood loss/donation >400 mL within 3 months (90 days) or planned donation/transfusion during the trial;
- Inability to avoid strenuous exercise within 14 days post-dosing;
- Substance abuse history or positive drug screening;
- Positive syphilis antibody test during screening;
- Clinically significant abnormalities in screening assessments (e.g., ALT >1.5×ULN, creatinine >ULN, neutrophils <1.5×10⁹/L, platelets <100×10⁹/L, hemoglobin <100 g/L);
- Pregnant/lactating women or positive pregnancy test;
- Needle phobia, poor venous access, or intolerance to venipuncture;
- Any other condition deemed by investigators to preclude compliance or safe participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Lanzhou Institute of Biological Products Co., Ltd.
Lanzhou, Gansu, 730000
About this study
Official title: 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
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.
Read the 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:
- to evaluate the pharmacokinetic (PK) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants;
- to evaluate the pharmacodynamic (PD) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants;
- to evaluate the immunogenicity of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants.
- Conditions
- Tetanus
- Being tested
- Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Human Tetanus Immunoglobulin, Placebo
- Keywords
- Tetanus Antitoxin
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody InjectionDrug
intramuscular injection
Human Tetanus ImmunoglobulinDrug
intramuscular injection
PlaceboDrug
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 105Days
Clinically significant changes in laboratory parameters from baseline at specified timepoints post-dosing
Complete Blood Count (CBC)
Measured: 105Days
Secondary outcomes (15)
Pharmacokinetic Endpoints
Cmax: Maximum plasma concentration
Measured: 105Days
Pharmacokinetic Endpoints
AUC~0-t: Area under the curve from 0 to last measurable timepoint
Measured: 105Days
Pharmacokinetic Endpoints
AUC~0-∞: Area under the curve extrapolated to infinity
Measured: 105Days
Pharmacokinetic Endpoints
T~max: Time to reach Cmax
Measured: 105Days
Pharmacokinetic Endpoints
t~1/2: Elimination half-life
Measured: 105Days
Pharmacokinetic Endpoints
CL/F: Apparent clearance
Measured: 105Days
Pharmacokinetic Endpoints
Vz/F：Apparent Volume of Distribution during Terminal Phase
Measured: 105Days
Pharmacokinetic Endpoints
MRT：Mean Residence Time
Measured: 105Days
Pharmacodynamic Endpoints
Change in tetanus-neutralizing antibody titer from baseline within 12 hours post-dose across treatment groups
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 105Days
Immunogenicity Endpoints
In participants who tested positive for anti-drug antibodies (ADA), the incidence of neutralizing antibodies (NAb) was assessed.
Measured: 105Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start18 Aug 2025
- Primary completion27 May 2026 (estimated)
- Study completion24 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lanzhou Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianchang He, Principal investigator, Yunnan Provinical Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149454
- Sponsor's protocol ID
- LIBP-TAB-01
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07149454
- Acronym / sponsor ID
- LIBP-TAB-01
- Conditions
- Tetanus
- Keywords
- Tetanus Antitoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Lanzhou Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 27 May 2026 (estimated)
- Study completion
- 24 Jun 2026 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to evaluate the pharmacokinetic (PK) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants;
- to evaluate the pharmacodynamic (PD) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants;
- to evaluate the immunogenicity of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 (0.2 mg dose group) | Experimental | Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Drug: PlaceboA 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. |
| Group 2 (2 mg dose group) | Experimental | Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Drug: PlaceboA 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. |
| Group 3 (5 mg dose group) | Experimental | Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Drug: PlaceboA 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. |
| Group 4 (10 mg dose group) | Experimental | Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Drug: Human Tetanus Immunoglobulin, Drug: PlaceboA 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. |
| Group 5 (15 mg dose group) | Experimental | Drug: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Drug: PlaceboA 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injectionintramuscular injection | Drug | 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 Immunoglobulinintramuscular injection | Drug | Group 4 (10 mg dose group) |
| Placebointramuscular injection | Drug | 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) |
Primary outcome
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Time frame: 105 days
Types of Adverse Events / Serious Adverse Reactions
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Time frame: 105Days
Incidence of Adverse Events/Serious Adverse Reactions
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Time frame: 105Days
Severity of Adverse Events (AEs)/Serious Adverse Reactions (SARs)
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Time frame: 105Days
Relationship of Adverse Events (AEs)/Serious Adverse Reactions (SARs) to the Investigational Product
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Time frame: 105Days
12-lead electrocardiogram examination：P Wave
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Time frame: 105Days
12-lead electrocardiogram examination：QRS Complex
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Time frame: 105Days
12-lead electrocardiogram examination：T Wave
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Time frame: 105Days
12-lead electrocardiogram examination：U Wave
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Time frame: 105Days
12-lead electrocardiogram examination：PR Interval
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Time frame: 105Days
12-lead electrocardiogram examination：QT Interval
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
Time frame: 105Days
12-lead electrocardiogram examination：ST Segment
Clinically significant changes in laboratory parameters from baseline at specified timepoints post-dosing
Time frame: 105Days
Complete Blood Count (CBC)
15 secondary outcomes
Pharmacokinetic Endpoints
Time frame: 105Days
Pharmacokinetic Endpoints
Time frame: 105Days
Pharmacokinetic Endpoints
Time frame: 105Days
Pharmacokinetic Endpoints
Time frame: 105Days
Pharmacokinetic Endpoints
Time frame: 105Days
Pharmacokinetic Endpoints
Time frame: 105Days
Pharmacokinetic Endpoints
Time frame: 105Days
Pharmacokinetic Endpoints
Time frame: 105Days
Pharmacodynamic Endpoints
Time frame: 0 to 12 hours
Pharmacodynamic Endpoints
Time frame: 105Days
Pharmacodynamic Endpoints
Time frame: 105Days
Exposure-Response Analysis, E-R Analysis
Time frame: 105Days
Immunogenicity Endpoints
Time frame: 105Days
Immunogenicity Endpoints
Time frame: 105Days
Immunogenicity Endpoints
Time frame: 105Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Tetanus
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianchang He principal investigator
Yunnan Provinical Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection and Human Tetanus Immunoglobulin in people with Tetanus, run by Lanzhou Institute of Biological Products Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit (time frame: 105 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.