Healthy Adult SubjectsPhase 1NCT04629131
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults
A Phase 1 study testing TNM002 Dosage 1 (10 μg/kg), TNM002 Dosage 2 (35 μg/kg) and TNM002 Dosage 3 (100 μg/kg) in people with Healthy Adult Subjects, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- TNM002 Dosage 1 (10 μg/kg), TNM002 Dosage 2 (35 μg/kg) and TNM002 Dosage 3 (100 μg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Nov 2020to 13 Aug 2021
- 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
- Each subject must meet the following criteria to be enrolled in this study:
- Healthy male or female, 18-55 years of age (both inclusive);
- Able to give signed written informed consent form;
- Able to well communicate with investigators as well as understand and adhere to the requirements of this study.
- Body mass index (BMI, weight [kg]/height [m]2) within 18.0-32.0 kg/m2 (both inclusive);
- Blood Pressure (BP) and 12-lead ECG showing no clinically significant abnormalities at the discretion of the Principal Investigator during screening;
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- Subjects having no clinically significant abnormality on physical examination, clinical laboratory tests, liver function or kidney function as determined by Principal Investigator (PI);
- Females must be either under surgical sterile (i.e. had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the first dose of study drug) or under postmenopausal for at least 1 year before the first dose of study drug or agree to use an acceptable method of contraception from screening until 90 days after last study drug administration. Males who are sexually active and who are partners of women of childbearing potential must agree to use effective contraception from screening until 90 days after last drug administration.
- acceptable method of contraception
- Use of intrauterine device
- Use of oral, injected or implanted hormonal methods of contraception
- Concomitant use of barrier contraception method
- Surgical contraception methods (e.g., vasectomy, salpingectomy, hysterectomy, etc.)
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- History or evidence of severe drug or excipient allergy, or hypersensitivity to other therapeutic mAbs;
- History or evidence of autoimmune disease or possible immunodeficiency state, including positive screening test for HIV;
- History or evidence of chronic hepatitis, including positive screening test for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody;
- History or evidence of tetanus infection, or exposure to tetanus vaccine within 6 months prior to the fist drug administration;
- Exposure to any live attenuated vaccine within 4 weeks prior to the fist drug administration;
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- Exposure to any inactivated vaccine within 2 weeks prior to the fist drug administration;
- History or evidence of any other acute or chronic disease that, in the opinion of the investigator, may have interfered with the evaluation of the safety or immunogenicity of the drug or compromised the safety of the subject; for example, a clinically relevant history of respiratory, thyroid, gastrointestinal, renal, hepatic, hematological, lymphatic, oncologic, cardiovascular, psychiatric, neurological, musculoskeletal, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease
- Subjects with surgery (except for minor outpatient surgery) within past 3 months prior to screening, or planned surgery during study;
- Subjects with intolerance or insufficient venous access to permit regular venepuncture;
- Known or suspected history of drug abuse within the past 5 years or with positive urine drug test at the screening;
- Donated blood >400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3months of screening; or donated blood >200 mL or significant blood loss equivalent to 200 mL within 1 month prior to the screening;
- Participation in any other clinical studies with chemical or biological drugs or device within 4 weeks or 5 times the half-life of the specific drug/biologics (whichever is longer), prior to the first drug administration;
- Use of any other drug, including over-the-counter medications, herb medicines within 14 days prior to the first drug administration (except for contraceptive medication in WOCBP, or concomitant medications that are considered necessary for the subject's welfare and unlikely to interfere with the study);
- Receipt of an Ig or blood product within 90 days prior to the first drug administration;
- Receipt of immunosuppressive medications, other than inhaled or topical immunosuppressant drugs, within 45 days prior to the first drug administration;
- Habitual use of nicotine products or smoking within 3 months (more than 5 cigarettes per day) prior to screening or unwilling to refrain from nicotine products during study participation;
- History of significant alcohol abuse within 6 months of screening or any indication of regular use of more than 14 units of alcohol per week (1 Unit=360 mL of beer or 45 mL of alcohol 40% or 150 mL of wine) or taking a product containing alcohol 2 days prior to dosing, or having a positive alcohol breath test during the screen period.;
- Malignancy within 5 years of screening visit (except basal cell skin carcinoma);
- Subject who is considered unsuitable for participating in the study in the opinion of investigator;
- Nursing mothers or pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in healthy adult subjects.
Read the detailed description
The study a randomized, double-blinded, placebo-controlled, dose-escalation phase I trial. A total of 32 healthy adult subjects will be enrolled into 4 cohorts sequentially. Each participant will receive a single IM dose of TNM002 or placebo according to the cohort in which they were enrolled. After injection (Day 1), participants remain in the study site for observation up to 5 days. Following completion of the safety assessments and sampling for PK/PD analyses on Day 4, participants will be discharged from the study site. On Day 8, 15, 29, 43, 64 and 85, participants will return for safety assessments.
- Conditions
- Healthy Adult Subjects
- Being tested
- TNM002 Dosage 1 (10 μg/kg), Placebo, TNM002 Dosage 2 (35 μg/kg), TNM002 Dosage 3 (100 μg/kg), TNM002 Dosage 4 (250 μg/kg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM002 Dosage 1 (10 μg/kg)Biological
TNM002 (human monoclonal antibody against tetanus toxin), 10 μg/kg, Intramuscular injection, given once.
PlaceboBiological
placebo to match TNM002 Dosage 1, given once
TNM002 Dosage 2 (35 μg/kg)Biological
TNM002 (human monoclonal antibody against tetanus toxin), 35 μg/kg, Intramuscular injection, given once
PlaceboBiological
placebo to match TNM002 Dosage 2, given once
TNM002 Dosage 3 (100 μg/kg)Biological
TNM002 (human monoclonal antibody against tetanus toxin), 100 μg/kg, Intramuscular injection, given once
PlaceboBiological
placebo to match TNM002 Dosage 3, given once
TNM002 Dosage 4 (250 μg/kg)Biological
TNM002 (human monoclonal antibody against tetanus toxin), 250 μg/kg, Intramuscular injection, given once
PlaceboBiological
placebo to match TNM002 Dosage 4, given once
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 TNM002 10 μg/kg/Placebo | Experimental | Sentinel dosing will be conducted for Cohort 1. Two participants will be dosed (1 with TNM002, 1 with placebo) at least 72 hours prior to subsequent dosing. The remaining participants will only be dosed if no significant safety signals are identified in the sentinel participants. In total, eight subjects will be randomly assigned to receive either TNM002 or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo). Receives: Biological: TNM002 Dosage 1 (10 μg/kg); Biological: Placebo |
| Cohort 2 TNM002 35 μg/kg/Placebo | Experimental | Eight subjects will be randomly assigned to receive either TNM002 or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo). Receives: Biological: TNM002 Dosage 2 (35 μg/kg); Biological: Placebo |
| Cohort 3 TNM002 100 μg/kg/Placebo | Experimental | Eight subjects will be randomly assigned to receive either TNM002 or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo). Receives: Biological: TNM002 Dosage 3 (100 μg/kg); Biological: Placebo |
| Cohort 4 TNM002 250 μg/kg/Placebo | Experimental | Eight subjects will be randomly assigned to receive either TNM002 or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo). Receives: Biological: TNM002 Dosage 4 (250 μg/kg); Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
The investigator will assess the intensity for each AE reported during the study based on the investigator's clinical judgment. Adverse events will be recorded according to CTCAE V5.0.
Measured: Up to 105 days post dosing
Clinically significant abnormality in physical examinations
clinically significant abnormality in general condition, skin, eyes/ears/nose/mouth/throat, neck/thyroid, chest/lungs, heart, vascular system, lymph nodes, abdomen, extremities, nervous systems/reflexes, musculoskeletal, spine
Measured: Up to 105 days post dosing
Change in RR intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in PR intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in QRS duration (msec)
Measured using a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in QT intervals (msec)
Calculated using measurements by a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in QTcB intervals (msec)
Calculated using measurements by a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in QTcF intervals (msec)
Calculated using measurements by a 12 Lead Electrocardiogram
Measured: Up to 105 days post dosing
Change in Semi recumbent blood pressure (mmHg)
Measured: Up to 105 days post dosing
Change in pulse rate (bpm)
Measured: Up to 105 days post dosing
Change in body temperature (celsius)
Measured: Up to 105 days post dosing
Change in Hematocrit (ratio)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Haemoglobin (g/L)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Mean corpuscular hemoglobin (pg)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Mean corpuscular hemoglobin concentration (g/L)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Mean corpuscular volume (fL)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Platelet count (cells x 10^9/L))
Measured by hematology test
Measured: Up to 105 days post dosing
Change in Red blood cell count (cells x 10^12/L)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in White blood cell count (cells x 10^9/L)
Measured by hematology test
Measured: Up to 105 days post dosing
Change in differential leukocyte count (cells x 10^9/L)
Including eosinophils, monocytes, lymphocytes, basophils, and neutrophils, Measured by hematology test
Measured: Up to 105 days post dosing
Change in Serum Alanine Aminotransferase (ALT) (U/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Albumin (g/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Alkaline Phosphatase (ALP) (U/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Aspartate Aminotransferase (AST) (U/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Total Bilirubin (umol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Blood urea nitrogen (BUN) (mmol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Calcium (mmol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Chloride (mmol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Cholesterol (mmol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Creatinine (umol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Creatine Kinase (U/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Glucose (mmol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Lactate Dehydrogenase (U/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Phosphorus (mmol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Potassium (mmol/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Serum Total protein (g/L)
measured by serum chemistry
Measured: Up to 105 days post dosing
Change in Urine Bilirubin (U-BIL)
measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine Glucose (GLU) (mg/dL)
measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine erythrocytes (U-RBC)
measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urinary leukocyte (U-LEU)
measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine nitrites (U-NIT)
measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine protein (U-PRO)
measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine specific gravity (U-SG)
measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Urine urobilinogen (URO)
measured by Urinalysis
Measured: Up to 105 days post dosing
Change in Prothrombin time (sec)
measured by Blood Coagulation test
Measured: Up to 105 days post dosing
Change in Activated partial thromboplastin time (APTT)(sec)
measured by Blood Coagulation test
Measured: Up to 105 days post dosing
Change in fibrinogen (g/L)
measured by Blood Coagulation test
Measured: Up to 105 days post dosing
Change in international normalized ratio (INR)
measured by Blood Coagulation test
Measured: Up to 105 days post dosing
Secondary outcomes (12)
Anti-TNM002 antibodies
The numbers of subjects who developed anti-TNM002 antibodies
Measured: Up to 105 days post dosing
Anti-TNM002 antibodies
The percentages of subjects who developed anti-TNM002 antibodies
Measured: Up to 105 days post dosing
Maximum observed plasma concentration (Cmax)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Time of maximum plasma concentration (Tmax)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Terminal half-life (T1/2)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Apparent oral clearance (CL/F)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Apparent volume of distribution (Vz/F)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Mean retention time (MRT)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Lambda z - the reciprocal of elimination rate constant
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
The ratio of area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last) extrapolated to AUC0-inf over AUC0-inf (% AUCex)
Estimated by non-compartmental analysis (NCA) with WinNonlin Version 7. 0 or above
Measured: Up to 105 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start25 Nov 2020
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TIGERMED AUSTRALIA PTY LIMITED
- Responsible party
- Sponsor
- Investigators
- Charlotte Lemech, FRACP, Principal investigator, Scientia Clinical Research Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629131
- Sponsor's protocol ID
- TNM002-P1-AU01
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in these articles, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04629131
- Acronym / sponsor ID
- TNM002-P1-AU01
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- TIGERMED AUSTRALIA PTY LIMITED
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 16 Nov 2020 (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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in healthy adult subjects.
Detailed description
The study a randomized, double-blinded, placebo-controlled, dose-escalation phase I trial. A total of 32 healthy adult subjects will be enrolled into 4 cohorts sequentially. Each participant will receive a single IM dose of TNM002 or placebo according to the cohort in which they were enrolled. After injection (Day 1), participants remain in the study site for observation up to 5 days. Following completion of the safety assessments and sampling for PK/PD analyses on Day 4, participants will be discharged from the study site. On Day 8, 15, 29, 43, 64 and 85, participants will return for safety assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 TNM002 10 μg/kg/Placebo | Experimental | Biological: TNM002 Dosage 1 (10 μg/kg), Biological: PlaceboSentinel dosing will be conducted for Cohort 1. Two participants will be dosed (1 with TNM002, 1 with placebo) at least 72 hours prior to subsequent dosing. The remaining participants will only be dosed if no significant safety signals are identified in the sentinel participants. In total, eight subjects will be randomly assigned to receive either TNM002 or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo). |
| Cohort 2 TNM002 35 μg/kg/Placebo | Experimental | Biological: TNM002 Dosage 2 (35 μg/kg), Biological: PlaceboEight subjects will be randomly assigned to receive either TNM002 or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo). |
| Cohort 3 TNM002 100 μg/kg/Placebo | Experimental | Biological: TNM002 Dosage 3 (100 μg/kg), Biological: PlaceboEight subjects will be randomly assigned to receive either TNM002 or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo). |
| Cohort 4 TNM002 250 μg/kg/Placebo | Experimental | Biological: TNM002 Dosage 4 (250 μg/kg), Biological: PlaceboEight subjects will be randomly assigned to receive either TNM002 or placebo at a 3:1 ratio (i.e. 6 subjects receive TNM002 and 2 with placebo). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male or female, 18-55 years of age (both inclusive);
- Able to give signed written informed consent form;
- Able to well communicate with investigators as well as understand and adhere to the requirements of this study.
- Body mass index (BMI, weight [kg]/height [m]2) within 18.0-32.0 kg/m2 (both inclusive);
- Blood Pressure (BP) and 12-lead ECG showing no clinically significant abnormalities at the discretion of the Principal Investigator during screening;
Key exclusion criteria (21 listed)
- History or evidence of severe drug or excipient allergy, or hypersensitivity to other therapeutic mAbs;
- History or evidence of autoimmune disease or possible immunodeficiency state, including positive screening test for HIV;
- History or evidence of chronic hepatitis, including positive screening test for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody;
- History or evidence of tetanus infection, or exposure to tetanus vaccine within 6 months prior to the fist drug administration;
- Exposure to any live attenuated vaccine within 4 weeks prior to the fist drug administration;
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 |
|---|---|---|
| TNM002 Dosage 1 (10 μg/kg)TNM002 (human monoclonal antibody against tetanus toxin), 10 μg/kg, Intramuscular injection, given once. | Biological | Cohort 1 TNM002 10 μg/kg/Placebo |
| Placeboplacebo to match TNM002 Dosage 1, given once | Biological | Cohort 1 TNM002 10 μg/kg/Placebo |
| TNM002 Dosage 2 (35 μg/kg)TNM002 (human monoclonal antibody against tetanus toxin), 35 μg/kg, Intramuscular injection, given once | Biological | Cohort 2 TNM002 35 μg/kg/Placebo |
| Placeboplacebo to match TNM002 Dosage 2, given once | Biological | Cohort 2 TNM002 35 μg/kg/Placebo |
| TNM002 Dosage 3 (100 μg/kg)TNM002 (human monoclonal antibody against tetanus toxin), 100 μg/kg, Intramuscular injection, given once | Biological | Cohort 3 TNM002 100 μg/kg/Placebo |
| Placeboplacebo to match TNM002 Dosage 3, given once | Biological | Cohort 3 TNM002 100 μg/kg/Placebo |
| TNM002 Dosage 4 (250 μg/kg)TNM002 (human monoclonal antibody against tetanus toxin), 250 μg/kg, Intramuscular injection, given once | Biological | Cohort 4 TNM002 250 μg/kg/Placebo |
| Placeboplacebo to match TNM002 Dosage 4, given once | Biological | Cohort 4 TNM002 250 μg/kg/Placebo |
Primary outcome
Incidence and severity of adverse events
Time frame: Up to 105 days post dosing
The investigator will assess the intensity for each AE reported during the study based on the investigator's clinical judgment. Adverse events will be recorded according to CTCAE V5.0.
Clinically significant abnormality in physical examinations
Time frame: Up to 105 days post dosing
clinically significant abnormality in general condition, skin, eyes/ears/nose/mouth/throat, neck/thyroid, chest/lungs, heart, vascular system, lymph nodes, abdomen, extremities, nervous systems/reflexes, musculoskeletal, spine
Change in RR intervals (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in PR intervals (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in QRS duration (msec)
Time frame: Up to 105 days post dosing
Measured using a 12 Lead Electrocardiogram
Change in QT intervals (msec)
Time frame: Up to 105 days post dosing
Calculated using measurements by a 12 Lead Electrocardiogram
Change in QTcB intervals (msec)
Time frame: Up to 105 days post dosing
Calculated using measurements by a 12 Lead Electrocardiogram
Change in QTcF intervals (msec)
Time frame: Up to 105 days post dosing
Calculated using measurements by a 12 Lead Electrocardiogram
Change in Semi recumbent blood pressure (mmHg)
Time frame: Up to 105 days post dosing
Change in pulse rate (bpm)
Time frame: Up to 105 days post dosing
Change in body temperature (celsius)
Time frame: Up to 105 days post dosing
Change in Hematocrit (ratio)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Haemoglobin (g/L)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Mean corpuscular hemoglobin (pg)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Mean corpuscular hemoglobin concentration (g/L)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Mean corpuscular volume (fL)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Platelet count (cells x 10^9/L))
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in Red blood cell count (cells x 10^12/L)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in White blood cell count (cells x 10^9/L)
Time frame: Up to 105 days post dosing
Measured by hematology test
Change in differential leukocyte count (cells x 10^9/L)
Time frame: Up to 105 days post dosing
Including eosinophils, monocytes, lymphocytes, basophils, and neutrophils, Measured by hematology test
Change in Serum Alanine Aminotransferase (ALT) (U/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Albumin (g/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Alkaline Phosphatase (ALP) (U/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Aspartate Aminotransferase (AST) (U/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Total Bilirubin (umol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Blood urea nitrogen (BUN) (mmol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Calcium (mmol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Chloride (mmol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Cholesterol (mmol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Creatinine (umol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Creatine Kinase (U/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Glucose (mmol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Lactate Dehydrogenase (U/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Phosphorus (mmol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Potassium (mmol/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Serum Total protein (g/L)
Time frame: Up to 105 days post dosing
measured by serum chemistry
Change in Urine Bilirubin (U-BIL)
Time frame: Up to 105 days post dosing
measured by Urinalysis
Change in Urine Glucose (GLU) (mg/dL)
Time frame: Up to 105 days post dosing
measured by Urinalysis
Change in Urine erythrocytes (U-RBC)
Time frame: Up to 105 days post dosing
measured by Urinalysis
Change in Urinary leukocyte (U-LEU)
Time frame: Up to 105 days post dosing
measured by Urinalysis
Change in Urine nitrites (U-NIT)
Time frame: Up to 105 days post dosing
measured by Urinalysis
Change in Urine protein (U-PRO)
Time frame: Up to 105 days post dosing
measured by Urinalysis
Change in Urine specific gravity (U-SG)
Time frame: Up to 105 days post dosing
measured by Urinalysis
Change in Urine urobilinogen (URO)
Time frame: Up to 105 days post dosing
measured by Urinalysis
Change in Prothrombin time (sec)
Time frame: Up to 105 days post dosing
measured by Blood Coagulation test
Change in Activated partial thromboplastin time (APTT)(sec)
Time frame: Up to 105 days post dosing
measured by Blood Coagulation test
Change in fibrinogen (g/L)
Time frame: Up to 105 days post dosing
measured by Blood Coagulation test
Change in international normalized ratio (INR)
Time frame: Up to 105 days post dosing
measured by Blood Coagulation test
12 secondary outcomes
Anti-TNM002 antibodies
Time frame: Up to 105 days post dosing
Anti-TNM002 antibodies
Time frame: Up to 105 days post dosing
Maximum observed plasma concentration (Cmax)
Time frame: Up to 105 days post dosing
Time of maximum plasma concentration (Tmax)
Time frame: Up to 105 days post dosing
Terminal half-life (T1/2)
Time frame: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
Time frame: Up to 105 days post dosing
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Time frame: Up to 105 days post dosing
Apparent oral clearance (CL/F)
Time frame: Up to 105 days post dosing
Apparent volume of distribution (Vz/F)
Time frame: Up to 105 days post dosing
Mean retention time (MRT)
Time frame: Up to 105 days post dosing
Lambda z - the reciprocal of elimination rate constant
Time frame: Up to 105 days post dosing
The ratio of area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last) extrapolated to AUC0-inf over AUC0-inf (% AUCex)
Time frame: Up to 105 days post dosing
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 7 Nov 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in these articles, after deidentification (text, tables, figures, and appendices)
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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.
Charlotte Lemech, FRACP principal investigator
Scientia Clinical Research Ltd
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 Dosage 1 (10 μg/kg), TNM002 Dosage 2 (35 μg/kg) and TNM002 Dosage 3 (100 μg/kg) in people with Healthy Adult Subjects, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in Australia.
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 13 inclusion and 21 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 7 Nov 2022. 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 Australia. 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?
Incidence and severity of adverse events (time frame: Up to 105 days post dosing). The study lists 48 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 7 Nov 2022; AzTrials last refreshed its copy on 9 Nov 2026.