Tetanus
Conditions
Keywords
Tetanus, Prophylaxis
Brief summary
TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.
Interventions
DRUGTNM002
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Sponsors
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Chinese male or female adults aged ≥ 18 years; 2. Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus; 3. Participants who provide signed written informed consent form.
Exclusion criteria
1. Known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins; 2. Suspect or diagnosed as tetanus; 3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies 4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine; 5. Current alcohol abuse, drug abuse or drug addiction Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level. | Baseline up to 12 hours after receipt of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Tetanus protection rate (1 - tetanus incidence) | Up to 28 days after receipt of study drug |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment related adverse events (AEs) | Up to 105 days after receipt of study drug | — |
| Incidence of serious adverse events (SAEs) | Up to 105 days after receipt of study drug | — |
| The number and percentage of subjects with abnormal hematology tests | Up to 90 days after receipt of study drug | The hemotology tests include red blood cell count, hemoglobin, platelet count, white blood cell count, absolute neutrophil count, neutrophil percentage, absolute lymphocyte count, lymphocytes percentage, absolute monocyte count, and hematocrit |
| The number and percentage of subjects with abnormal serum chemistry tests | Up to 90 days after receipt of study drug | The serum chemistry tests include total protein, albumin, sodium, potassium, chloride, calcium, glucose, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct bilirubin, urea (blood urea nitrogen) and creatinine |
| The number and percentage of subjects with abnormal urinalysis tests | Up to 90 days after receipt of study drug | The urinalysis tests include protein, glucose, urobilinogen, urine occult blood, red blood cell and white blood cell |
| The number and percentage of subjects with abnormal vital signs | Up to 90 days after receipt of study drug | The vital signs include blood pressure, pulse rate, respiratory rate, and body temperature |
| The number and percentage of subjects with abnormal physical examination | Up to 90 days after receipt of study drug | The physical examination includes skin, lymph nodes, eyes, head and neck, chest, abdomen, spine, extremities. |
| The number and percentage of subjects with abnormal 12-lead electrocardiogram (ECG) | Up to 90 days after receipt of study drug | — |
| Incidence of adverse events (AEs) | Up to 105 days after receipt of study drug | — |
Countries
China
Outcome results
None listed