A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection

Официальное название

A Multicentre, Randomized, Double-blind, Human Tetanus Immunoglobulin(HTIG) Controlled Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection for Indication of Prophylaxis Against Tetanus

Обзор

The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.

Вмешательства

• Биопрепарат GR2001
  The packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial.
• Биопрепарат HTIG
  The HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form.

Первичные конечные точки

• The increase of anti-tetanus neutralizing antibody titers (∆ titers) [Срок оценки: Baseline up to 12 hours after receipt of Investigational medicinal product.]

Вторичные конечные точки (5)

• The incidence of tetanus [Срок оценки: Up to 105 days after receipt of Investigational medicinal product.]
• To evaluate the safety of GR2001 [Срок оценки: Up to 105 days after receipt of Investigational medicinal product.]
• To evaluate the peak plasma concentration(Cmax) of GR2001 [Срок оценки: Up to 105 days after receipt of Investigational medicinal product.]
• To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001 [Срок оценки: Up to 105 days after receipt of Investigational medicinal product.]
• To evaluate the immunogenicity of GR2001 [Срок оценки: Up to 105 days after receipt of Investigational medicinal product.]

Критерии участия

Критерии включения

• Chinese male or female adults aged ≥ 18 years；
• Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
• Participants who provide signed written informed consent form.

Критерии исключения

• Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
• Suspect or diagnosed as tetanus;
• Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies；
• Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
• Females who are pregnant or with pregnancy test positive.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 20 центров

• The Second Affiliated Hospital of Anhui Medical University — Хэфэй
• Peking University First Hospital — Пекин
• Peking University People Hospital — Пекин
• Beijing Tiantan Hospital — Пекин
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The Third Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Zhujiang Hospital Affiliated to Southern Medical University — Гуанчжоу
• Shenzhen Second People's Hospital — Шэньчжэнь
• … и ещё 12 центров

Идентификаторы

NCT: NCT06635798 · GR2001-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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