Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers

Trinomab

Status and phase: Completed; Phase 2

Conditions: Tetanus

Treatments: Biological: Placebo; Biological: HTIG; Biological: TNM002 (high dose); Biological: TNM002 (low dose); Biological: TNM002 (medium dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05625477

TNM002-P2-CH01

Details and patient eligibility

About

The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Chinese male or female adults aged ≥ 18 years;
2. Healthy volunteers or volunteers with stable chronic diseases;
3. Volunteers who provide signed written informed consent form.

Exclusion criteria

1. History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
2. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
3. History of alcohol or other substance abuse.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 5 patient groups, including a placebo group

TNM002 low dose

Experimental group

Description:

Participants receive a single intramuscular injection of TNM002 with low dose on Day 1

Treatment:

Biological: TNM002 (low dose)

TNM002 medium dose

Experimental group

Description:

Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1

Treatment:

Biological: TNM002 (medium dose)

TNM002 high dose

Experimental group

Description:

Participants receive a single intramuscular injection of TNM002 with high dose on Day 1

Treatment:

Biological: TNM002 (high dose)

Human Tetanus Immunoglobulin (HTIG)

Active Comparator group

Description:

Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1

Treatment:

Biological: HTIG

Placebo

Placebo Comparator group

Description:

Participants receive a single intramuscular injection of placebo on Day 1

Treatment:

Biological: Placebo