A Phase Ⅲ Clinical Study of SNA02-48 Injection

Официальное название

A Multicenter, Randomized, Double-Blind, Active-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of SNA02-48 Injection in Populations With High-Risk Tetanus Exposure

Обзор

The primary objective of this clinical trial is to compare the efficacy and safety of SNA02-48 injection with Human Tetanus Immunoglobulin (HTIG) for tetanus prophylaxis.

Вмешательства

• Препарат SNA02-48
  IM gluteal injection
• Препарат Human tetanus immunoglobulin (HTIG)
  IM gluteal injection

Первичные конечные точки

• The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level. [Срок оценки: Baseline up to 12 hours after receipt of study drug]

Вторичные конечные точки (6)

• The incidence of tetanus [Срок оценки: Up to 105 days after receipt of study drug]
• anti-tetanus neutralizing antibody titers [Срок оценки: Up to 90 days after receipt of study drug]
• Incidence of adverse events [Срок оценки: Up to 105 days after receipt of study drug]
• Incidence of severe adverse events (SAEs) [Срок оценки: Up to 105 days after receipt of study drug]
• To evaluate the plasma concentration of SNA02-48 [Срок оценки: Up to 90 days after receipt of study drug]
• Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab) [Срок оценки: Up to 90 days after receipt of study drug]

Критерии участия

Критерии включения

• Males or females aged 18 years and above;
• Participants who can understand and voluntarily sign the informed consent form;
• Participants with high-risk tetanus exposure;
• Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures from the time the participant signs the informed consent form until 6 months after administration, with no plans for sperm or egg donation.

Критерии исключения

• Suspected or confirmed tetanus ;
• A history of previous tetanus infection;
• A known history of 3 or more doses of tetanus toxoid or vaccines containing tetanus toxoid, or fewer than 3 previous doses but with the last dose of tetanus toxoid or vaccines containing tetanus toxoid administered within 6 months prior to the administration of the investigational product;
• Known hypersensitivity to the investigational product (including excipients, HTIG, and other therapeutic monoclonal antibodies), or suffering from severe allergic diseases that, in the investigator's judgment, may impair the participant's safety; Other protocol defined Inclusion/Exclusion criteria may apply.

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 · 30 центров

• Taihe County People's Hospital — Fuyang
• The Second Affiliated Hospital of Anhui Medical University — Хэфэй
• Peking University First Hospital — Пекин
• Peking University People's Hospital — Пекин
• Beijing Tiantan Hospital Affiliated to Capital Medical University — Пекин
• Peking Union Medical College Hospital — Пекин
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The Third Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• … и ещё 22 центра

Идентификаторы

NCT: NCT07633119 · PRO-SNA02-48-3001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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