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

NCT06607380 | Completed Phase 1 FDA Drug

• 1 other identifier: TNM002-P1-CH02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

• 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

• 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

Study Arms (3)

Group 1

EXPERIMENTAL

TNM002

Biological: TNM002

Group 2

ACTIVE COMPARATOR

Adsorbed tetanus vaccine

Biological: Adsorbed tetanus vaccine

Group 3

EXPERIMENTAL

TNM002 + adsorbed tetanus vaccine

Biological: TNM002 + adsorbed tetanus vaccine

Interventions

TNM002 BIOLOGICAL

A single intramuscular (IM) gluteal injection

Group 1

Adsorbed tetanus vaccine BIOLOGICAL

A single IM deltoid injection

Group 2

TNM002 + adsorbed tetanus vaccine BIOLOGICAL

A single IM gluteal injection+ a single IM deltoid injection

Group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, 18-55 years of age (inclusive) at enrollment;
• Subjects who voluntarily provide signed written ICF;
• Subjects who are able to well communicate with investigator as well as understand and adhere to the requirements of this study;

You may not qualify if:

• 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;
• Exposure to tetanus vaccines or vaccines containing antigenic components of tetanus toxoid within the past 10 years;
• Exposure to tetanus immunoglobulin, receipt of blood transfusion or use of blood products within the past 6 months prior to screening;
• History or family history of neurologic symptoms such as convulsions, epilepsy, encephalopathy and psychosis;
• Subjects with thrombopenia or other coagulation disorders, or bleeding constitution or bleeding time prolongation, which may cause contraindications to IM injection;
• 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;
• Receipt of immunosuppressants or immunopotentiators, other than inhaled or topical immunosuppressants within 3 months prior to dosing;
• 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);
• History of surgery within 3 months prior to screening, or planned surgery during the study;
• 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;
• 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;
• Use of any other drug, including over-the-counter medications and Chinese herbal medicines within 14 days prior to dosing ;
• Exposure to other vaccines within 1 month prior to dosing, or plan to receive live vaccines within 3 months after dosing;
• Pregnant or lactating women;

Sponsors & Collaborators

• Zhuhai Trinomab Pharmaceutical Co., Ltd.: lead

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, Shandong, 255000, China

Location

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jie Hou, Doctor

  Peking University Care Luzhong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 23, 2024
• Study Start: August 13, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 17, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months and ending 5 years following article publication.
• Access Criteria: Academics who provide a methodologically sound proposal. The leading clinical site and sponsor will review the request.

Locations

CN (1)