Sintetol (siltartoxatug) / Guangzhou Trinomab Biotechnology - LARVOL DELTA

A Multicenter, Randomized, Open-Label, Active-Controlled, Superiority Trial of Siltartoxatug Injection for the Prevention of Tetanus in Severe Trauma Patients at High Risk of Infection (ChiCTR) - P4 | N=300 | Not yet recruiting | Sponsor: The First People's Hospital of Changzhou; The First People's Hospital of Changzhou

Head-to-Head • New P4 trial • Infectious Disease • Mood Disorders • Tetanus

Phase I Evaluation of Siltartoxatug, a First-in-Class Anti-Tetanus Monoclonal Antibody: Safety, Pharmacokinetics and Pharmacodynamics in Healthy Australian and Chinese Populations. (PubMed, Clin Pharmacol Ther) - "These findings collectively highlighted siltartoxatug's potential as a next-generation passive immunizing agent. The consistent PK/PD profiles between Australian and Chinese populations suggested no apparent ethnic differences, providing a foundation for extrapolating efficacy findings from the Chinese trials to other racial groups."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Tetanus

Real-world use of monoclonal anti-tetanus toxin antibody for post-traumatic passive immunization: A nationwide survey in China. (PubMed, Chin J Traumatol) - "Standardized wound assessment and appropriate selection of passive immunization agents are crucial for tetanus prevention. Monoclonal anti-tetanus toxin antibody represents an effective and promising option for passive immunization against tetanus."

Journal • Real-world evidence • Infectious Disease • Tetanus

A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury (clinicaltrials.gov) - P=N/A | N=6000 | Recruiting | Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Tetanus

A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

New P1 trial • Infectious Disease • Tetanus

Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus (clinicaltrials.gov) - P3 | N=675 | Completed | Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2023 ➔ Mar 2023

Trial primary completion date • Infectious Disease • Tetanus

Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus (clinicaltrials.gov) - P3 | N=675 | Completed | Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Tetanus

Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus (clinicaltrials.gov) - P3 | N=675 | Active, not recruiting | Sponsor: Trinomab Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Tetanus

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Trinomab Biotech Co., Ltd.

New P1 trial

Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus (clinicaltrials.gov) - P3 | N=675 | Recruiting | Sponsor: Trinomab Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Tetanus

Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus (clinicaltrials.gov) - P3 | N=675 | Not yet recruiting | Sponsor: Trinomab Biotech Co., Ltd.

New P3 trial • Infectious Disease • Tetanus

Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers (clinicaltrials.gov) - P2 | N=240 | Completed | Sponsor: Trinomab Biotech Co., Ltd.

New P2 trial • Infectious Disease • Tetanus