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

NCT ID: NCT06607380

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-13
• Study Completion Date: 2023-04-17

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.

Conditions

Tetanus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

TNM002

Group Type: EXPERIMENTAL

TNM002

Intervention Type: BIOLOGICAL

A single intramuscular (IM) gluteal injection

Group 2

Adsorbed tetanus vaccine

Group Type: ACTIVE_COMPARATOR

Adsorbed tetanus vaccine

Intervention Type: BIOLOGICAL

A single IM deltoid injection

Group 3

TNM002 + adsorbed tetanus vaccine

Group Type: EXPERIMENTAL

TNM002 + adsorbed tetanus vaccine

Intervention Type: BIOLOGICAL

A single IM gluteal injection+ a single IM deltoid injection

Interventions

TNM002

A single intramuscular (IM) gluteal injection

Intervention Type: BIOLOGICAL

Adsorbed tetanus vaccine

A single IM deltoid injection

Intervention Type: BIOLOGICAL

TNM002 + adsorbed tetanus vaccine

A single IM gluteal injection+ a single IM deltoid injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhuhai Trinomab Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Hou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Care Luzhong Hospital

Locations

PKUCare Luzhong Hospital

Zibo, Shandong, China

Countries

China

Other Identifiers

TNM002-P1-CH02

Identifier Type: -

Identifier Source: org_study_id