NCT07206758招募中1 期
A Phase I Study Evaluating the Safety, Efficacy, Pharmacokinetics and Pharmacokinetics of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年11月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The incidence of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)
研究概览
简要总结
Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants must fully understand the trial content, procedures, and potential adverse reactions, and voluntarily sign a written informed consent form (ICF).
- •Age at signing the ICF must be ≥ 18 years (including the boundary value), regardless of gender.
- •Confirmed diagnosis of primary ITP for at least 3 months at screening.
- •Previous treatment with corticosteroids.
- •At the last ITP treatment, participants experienced loss of remission, no remission, relapse after remission, or intolerance.
- •Platelet count <30×10⁹/L at screening with clinical assessment indicating treatment necessity
- •Participants must have adequate organ function
- •Clinically stable condition with World Health Organization (WHO) bleeding scale grade 0-1
- •Female participants of childbearing potential or male participants with fertile partners must refrain from sperm/ova donation from ICF signing until 12 weeks after last dose and agree to protocol-specified contraceptive measures
排除标准
- •Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia
- •Received platelet transfusion, whole blood transfusion, plasma exchange, or any other emergency treatment drugs within 14 days prior to the first infusion of SHR-2173
- •Received immunosuppressants (other than corticosteroids) such as Janus kinase [JAK] inhibitors or Bruton tyrosine kinase [BTK] inhibitors within either 5 times the drug elimination half-life or 14 days prior to the first infusion of SHR-2173 (whichever is longer)
- •Previous treatment with SHR-2173
- •Screening prothrombin time or activated partial thromboplastin time outside the normal range; concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medications (e.g., warfarin, clopidogrel, novel oral anticoagulants), except for low-dose acetylsalicylic acid
- •History of any thrombotic or embolic events within 12 months prior to the first administration, or clinical symptoms and history suggesting thrombophilia
- •Current life-threatening bleeding (related to thrombocytopenia) or expected to require emergency treatment within one week after randomization
- •Active viral, bacterial, or other infections (including tuberculosis [TB]) requiring systemic treatment at screening, or SARS-CoV-2 infection during screening, or history of clinically significant recurrent infections
- •Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live/attenuated vaccinations during the trial
- •Received live or attenuated live vaccines within 8 weeks prior to the first administration of SHR-2173, or planned to receive live/attenuated vaccinations during the trial
- •Diagnosis of myelodysplastic syndrome; history of or current malignancy within 5 years prior to screening (except for cured non-melanoma skin cancer, in situ carcinoma [e.g., cervical, breast, bladder, prostate cancer], and cancers in complete remission for at least 5 years with no evidence of recurrence)
- •Previous splenectomy
- •Previous allogeneic stem cell or organ transplantation (except for corneal transplantation ≥ 3 months prior to screening); known or suspected history of immunosuppression
- •Planned surgery during the dosing period
- •Any severe and/or unstable pre-existing medical, psychiatric, or other conditions that the investigator judges may interfere with patient safety, obtaining informed consent, or compliance with study procedures
- •Allergic constitution (e.g., allergies to two or more drugs, foods, or pollens) or known hypersensitivity (immediate or delayed) or atopic reactions to the study drug (including excipients, monoclonal antibodies)
- •Concurrent participation in other investigational studies within either 30 days prior to enrollment or 5 half-lives of the investigational drug (whichever is longer)
- •Females who are lactating or pregnant (positive serum or urine β-human chorionic gonadotropin [hCG]) at screening or on Day 1 of Week 1 prior to administration
研究组 & 干预措施
SHR-2173 Injection
Experimental
干预措施: SHR-2173 Injection (Drug)
结局指标
主要结局
The incidence of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)
时间窗: About in the ninth month
The severity of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)
时间窗: About in the ninth month
Changes in abnormal indicators in laboratory inspection
时间窗: About in the ninth month
次要结局
- Percentage of subjects achieving remission response at week 13 of the treatment period(About in the fourth month)
- Percentage of subjects achieving remission response at week 25 of the treatment period(About in the sixth month)
- Proportion of participants achieving confirmed remission after SHR-2173 injection treatment(About in the ninth month)
- Number and severity of bleeding events(About in the ninth month)
- Percentage of participants requiring rescue therapy(About in the ninth month)
- Percentage of participants achieving remission response at any time during the treatment period(About in the ninth month)
- Time from first SHR-2173 injection treatment to confirmed remission(About in the ninth month)
- Duration from first confirmed remission to date of remission loss(About in the ninth month)
- Anti-SHR-2173 antibodies(About in the ninth month)
- Serum concentration of SHR-2173(About in the ninth month)
- Serum immunoglobulin levels(About in the ninth month)
- Count and percentage of B cells and subsets in peripheral blood(About in the ninth month)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of SHR-1707 With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's DiseaseAlzheimer's DiseaseNCT05681819Shanghai Hengrui Pharmaceutical Co., Ltd.33
已完成
2 期
Efficacy and Safety of SHR-1918 in Patients With HyperlipidemiaHyperlipidemiaNCT06471218Beijing Suncadia Pharmaceuticals Co., Ltd44
已完成
2 期
A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)Macular EdemaDiabetic RetinopathyNCT03071068ThromboGenics49
终止
2 期
Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease PatientsAlzheimer's DiseaseNCT06199037Shanghai Hengrui Pharmaceutical Co., Ltd.46
已完成
2 期
A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)Retinal TelangiectasisIdiopathic Juxtafoveal Retinal TelangiectasiaNCT03669393ThromboGenics8