TetanusPhase 1NCT06607380
A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine
A Phase 1 study testing TNM002, Adsorbed tetanus vaccine and TNM002 + adsorbed tetanus vaccine in people with Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is designed as a randomized, open-label, parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK, PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine, and to evaluate the safety and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- TNM002, Adsorbed tetanus vaccine and TNM002 + adsorbed tetanus vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2022to 17 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, 18-55 years of age (inclusive) at enrollment;
- Subjects who voluntarily provide signed written ICF;
- Subjects who are able to well communicate with investigator as well as understand and adhere to the requirements of this study;
Who cannot join
- Previous history of gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncologic, respiratory, immunological, cardiovascular and cerebrovascular diseases, which, as judged by the investigator, may affect the safety of the patient or may affect the PK, PD or immunogenicity assessment of this study;
- Exposure to tetanus vaccines or vaccines containing antigenic components of tetanus toxoid within the past 10 years;
- Exposure to tetanus immunoglobulin, receipt of blood transfusion or use of blood products within the past 6 months prior to screening;
- History or family history of neurologic symptoms such as convulsions, epilepsy, encephalopathy and psychosis;
- Subjects with thrombopenia or other coagulation disorders, or bleeding constitution or bleeding time prolongation, which may cause contraindications to IM injection;
- Subjects with any acute illness requiring systemic antibiotics or antiviral therapy within 7 days prior to screening. Subjects with fever within 3 days prior to screening;
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- Receipt of immunosuppressants or immunopotentiators, other than inhaled or topical immunosuppressants within 3 months prior to dosing;
- Allergy to the investigational product or its excipients, or have a history of allergy to vaccines or human immunoglobulin products or other therapeutic monoclonal antibodies (mAbs);
- History of surgery within 3 months prior to screening, or planned surgery during the study;
- Known or suspected history of drug abuse within 5 years prior to screening, or with positive urine drug abuse screening result; or a previous history of drug addiction;
- Participation in other clinical studies with the investigational drugs or devices within 3 months or within 5 times the half-life of the specific drugs/biological products prior to dosing, except for observational, non-interventional clinical studies;
- Use of any other drug, including over-the-counter medications and Chinese herbal medicines within 14 days prior to dosing ;
- Exposure to other vaccines within 1 month prior to dosing, or plan to receive live vaccines within 3 months after dosing;
- Pregnant or lactating women;
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine Administered Alone and Simultaneously Administered in Chinese Healthy Subjects
This study is designed as a randomized, open-label, parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK, PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine, and to evaluate the safety and tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine.
- Conditions
- Tetanus
- Being tested
- TNM002, Adsorbed tetanus vaccine, TNM002 + adsorbed tetanus vaccine
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM002Biological
A single intramuscular (IM) gluteal injection
Adsorbed tetanus vaccineBiological
A single IM deltoid injection
TNM002 + adsorbed tetanus vaccineBiological
A single IM gluteal injection+ a single IM deltoid injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | TNM002 Receives: Biological: TNM002 |
| Group 2 | Active comparator | Adsorbed tetanus vaccine Receives: Biological: Adsorbed tetanus vaccine |
| Group 3 | Experimental | TNM002 + adsorbed tetanus vaccine Receives: Biological: TNM002 + adsorbed tetanus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of TNM002, area under the plasma concentration-time curve from time 0 to the last quantifiable time point post-dose (AUC0-last)
Measured: Up to Day 106
Percentage of subjects with an increase of serum TNM002-specific anti-tetanus neutralizing antibody titers (ΔTiters) ≥ 0.01 IU/mL from baseline at 24 hours after immunization
Measured: Up to 24 hours after administration
Percentage of subjects with serum anti-tetanus antibody titers ≥ 0.1 IU/mL on 28 days after immunization
Measured: Up to 28 days after administration
Secondary outcomes (8)
Time to maximum serum TNM002 concentration (Tmax), elimination half-life (t1/2), and if data permit, apparent clearance (CL/F) and apparent volume of distribution (Vz/F) after immunization
Measured: Up to Day 106
Percentage of subjects with anti-tetanus neutralizing antibody ΔTiters ≥ 0.01 IU/mL at post-dose time points other than 24 hours after immunization
Measured: Up to Day 106
Serum TNM002-specific anti-tetanus neutralizing antibody titer and ΔTiters at each post-dose time point after immunization
Measured: Up to Day 106
Percentage of subjects with anti-tetanus antibody titer ≥ 0.1 IU/mL at post-dose time points other than 28 days after immunization
Measured: Up to Day 106
Percentage of subjects with serum anti-tetanus antibody titer ≥ 1.0 IU/mL at each post-dose time point after immunization
Measured: Up to Day 106
Serum anti-tetanus antibody titers, and fold increases from baseline at each post-dose time point
Measured: Up to Day 106
Adverse events (AEs), safety laboratory test, 12-lead electrocardiogram (ECG), physical examination, and vital signs
Measured: Up to Day 106
Percentage of subjects with positive anti-TNM002 antibody (ADA) in serum.
Measured: Up to Day 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start13 Aug 2022
- Primary completion10 Apr 2023
- Study completion17 Apr 2023
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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Hou, Doctor, Principal investigator, Peking University Care Luzhong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607380
- Sponsor's protocol ID
- TNM002-P1-CH02
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine Administered Alone and Simultaneously Administered in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06607380
- Acronym / sponsor ID
- TNM002-P1-CH02
- Conditions
- Tetanus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 23 Sep 2024 (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.
This study is designed as a randomized, open-label, parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK, PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine, and to evaluate the safety and tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: TNM002TNM002 |
| Group 2 | Active comparator | Biological: Adsorbed tetanus vaccineAdsorbed tetanus vaccine |
| Group 3 | Experimental | Biological: TNM002 + adsorbed tetanus vaccineTNM002 + adsorbed tetanus vaccine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female, 18-55 years of age (inclusive) at enrollment;
- Subjects who voluntarily provide signed written ICF;
- Subjects who are able to well communicate with investigator as well as understand and adhere to the requirements of this study;
Key exclusion criteria (15 listed)
- Previous history of gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncologic, respiratory, immunological, cardiovascular and cerebrovascular diseases, which, as judged by the investigator, may affect the safety of the patient or may affect the PK, PD or immunogenicity assessment of this study;
- Exposure to tetanus vaccines or vaccines containing antigenic components of tetanus toxoid within the past 10 years;
- Exposure to tetanus immunoglobulin, receipt of blood transfusion or use of blood products within the past 6 months prior to screening;
- History or family history of neurologic symptoms such as convulsions, epilepsy, encephalopathy and psychosis;
- Subjects with thrombopenia or other coagulation disorders, or bleeding constitution or bleeding time prolongation, which may cause contraindications to IM injection;
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 |
|---|---|---|
| TNM002A single intramuscular (IM) gluteal injection | Biological | Group 1 |
| Adsorbed tetanus vaccineA single IM deltoid injection | Biological | Group 2 |
| TNM002 + adsorbed tetanus vaccineA single IM gluteal injection+ a single IM deltoid injection | Biological | Group 3 |
Primary outcome
Maximum concentration (Cmax) of TNM002, area under the plasma concentration-time curve from time 0 to the last quantifiable time point post-dose (AUC0-last)
Time frame: Up to Day 106
Percentage of subjects with an increase of serum TNM002-specific anti-tetanus neutralizing antibody titers (ΔTiters) ≥ 0.01 IU/mL from baseline at 24 hours after immunization
Time frame: Up to 24 hours after administration
Percentage of subjects with serum anti-tetanus antibody titers ≥ 0.1 IU/mL on 28 days after immunization
Time frame: Up to 28 days after administration
8 secondary outcomes
Time to maximum serum TNM002 concentration (Tmax), elimination half-life (t1/2), and if data permit, apparent clearance (CL/F) and apparent volume of distribution (Vz/F) after immunization
Time frame: Up to Day 106
Percentage of subjects with anti-tetanus neutralizing antibody ΔTiters ≥ 0.01 IU/mL at post-dose time points other than 24 hours after immunization
Time frame: Up to Day 106
Serum TNM002-specific anti-tetanus neutralizing antibody titer and ΔTiters at each post-dose time point after immunization
Time frame: Up to Day 106
Percentage of subjects with anti-tetanus antibody titer ≥ 0.1 IU/mL at post-dose time points other than 28 days after immunization
Time frame: Up to Day 106
Percentage of subjects with serum anti-tetanus antibody titer ≥ 1.0 IU/mL at each post-dose time point after immunization
Time frame: Up to Day 106
Serum anti-tetanus antibody titers, and fold increases from baseline at each post-dose time point
Time frame: Up to Day 106
Adverse events (AEs), safety laboratory test, 12-lead electrocardiogram (ECG), physical examination, and vital signs
Time frame: Up to Day 106
Percentage of subjects with positive anti-TNM002 antibody (ADA) in serum.
Time frame: Up to Day 106
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification.
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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. This study is not recruiting at the moment.
Jie Hou, Doctor principal investigator
Peking University Care Luzhong Hospital
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 TNM002, Adsorbed tetanus vaccine and TNM002 + adsorbed tetanus vaccine in people with Tetanus, run by Zhuhai Trinomab Pharmaceutical 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 3 inclusion and 15 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: finished, as of the sponsor's last update on 23 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum concentration (Cmax) of TNM002, area under the plasma concentration-time curve from time 0 to the last quantifiable time point post-dose (AUC0-last) (time frame: Up to Day 106). The study lists 3 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 23 Sep 2024.