A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine

Trinomab

Status and phase: Completed; Phase 1

Conditions: Tetanus

Treatments: Biological: TNM002; Biological: TNM002 + adsorbed tetanus vaccine; Biological: Adsorbed tetanus vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06607380

TNM002-P1-CH02

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Group 1

Experimental group

Description:

TNM002

Treatment:

Biological: TNM002

Group 2

Active Comparator group

Description:

Adsorbed tetanus vaccine

Treatment:

Biological: Adsorbed tetanus vaccine

Group 3

Experimental group

Description:

TNM002 + adsorbed tetanus vaccine

Treatment:

Biological: TNM002 + adsorbed tetanus vaccine