NCT06635798招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- The increase of anti-tetanus neutralizing antibody titers (∆ titers)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
GR2001
Experimental
If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001
干预措施: GR2001 (Biological)
HTIG
Active Comparator
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
干预措施: HTIG (Biological)
结局指标
主要结局
The increase of anti-tetanus neutralizing antibody titers (∆ titers)
时间窗: Baseline up to 12 hours after receipt of Investigational medicinal product.
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
次要结局
- The incidence of tetanus(Up to 105 days after receipt of Investigational medicinal product.)
- To evaluate the safety of GR2001(Up to 105 days after receipt of Investigational medicinal product.)
- To evaluate the peak plasma concentration(Cmax) of GR2001(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(Up to 105 days after receipt of Investigational medicinal product.)
- To evaluate the immunogenicity of GR2001(Up to 105 days after receipt of Investigational medicinal product.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Study to Evaluate GR1801's Efficacy and SafetyRabies Post-exposure ProphylaxisNCT05846568Genrix (Shanghai) Biopharmaceutical Co., Ltd.1,200
已完成
2 期
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)Acquired Immunodeficiency SyndromeHIV InfectionsNCT00100048Merck Sharp & Dohme LLC206
已完成
1 期
First Time in Human Study Using GSK2330672Diabetes Mellitus, Type 2NCT01416324GlaxoSmithKline17
已完成
3 期
Efficacy Study of GS010 for the Treatment of Vision Loss up to 6 Months From Onset in LHON Due to the ND4 MutationOptic, Atrophy, Hereditary, LeberNCT02652767GenSight Biologics39
招募中
1 期
The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple MyelomaSmoldering Multiple MyelomaMultiple MyelomaNCT05841550Oslo University Hospital20