Tetanus
Conditions
Brief 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 tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine.
Interventions
BIOLOGICALTNM002
A single intramuscular (IM) gluteal injection
BIOLOGICALAdsorbed tetanus vaccine
A single IM deltoid injection
BIOLOGICALTNM002 + adsorbed tetanus vaccine
A single IM gluteal injection+ a single IM deltoid injection
Sponsors
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female, 18-55 years of age (inclusive) at enrollment; 2. Subjects who voluntarily provide signed written ICF; 3. Subjects who are able to well communicate with investigator as well as understand and adhere to the requirements of this study;
Exclusion criteria
1. 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; 2. Exposure to tetanus vaccines or vaccines containing antigenic components of tetanus toxoid within the past 10 years; 3. Exposure to tetanus immunoglobulin, receipt of blood transfusion or use of blood products within the past 6 months prior to screening; 4. History or family history of neurologic symptoms such as convulsions, epilepsy, encephalopathy and psychosis; 5. Subjects with thrombopenia or other coagulation disorders, or bleeding constitution or bleeding time prolongation, which may cause contraindications to IM injection; 6. 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; 7. Receipt of immunosuppressants or immunopotentiators, other than inhaled or topical immunosuppressants within 3 months prior to dosing; 8. 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); 9. History of surgery within 3 months prior to screening, or planned surgery during the study; 10. 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; 11. 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; 12. Use of any other drug, including over-the-counter medications and Chinese herbal medicines within 14 days prior to dosing ; 13. Exposure to other vaccines within 1 month prior to dosing, or plan to receive live vaccines within 3 months after dosing; 14. Pregnant or lactating women; Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | 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 | Up to 24 hours after administration |
| Percentage of subjects with serum anti-tetanus antibody titers ≥ 0.1 IU/mL on 28 days after immunization | Up to 28 days after administration |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with anti-tetanus antibody titer ≥ 0.1 IU/mL at post-dose time points other than 28 days after immunization | 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 | Up to Day 106 |
| 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 | Up to Day 106 |
| Adverse events (AEs), safety laboratory test, 12-lead electrocardiogram (ECG), physical examination, and vital signs | Up to Day 106 |
| Percentage of subjects with positive anti-TNM002 antibody (ADA) in serum. | Up to Day 106 |
| Serum anti-tetanus antibody titers, and fold increases from baseline at each post-dose time point | 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 | Up to Day 106 |
| Serum TNM002-specific anti-tetanus neutralizing antibody titer and ΔTiters at each post-dose time point after immunization | Up to Day 106 |
Countries
China
Outcome results
None listed