Status:
RECRUITING
Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07206758
Start Date
November 12 2025
End Date
November 1 2026
Last Update
November 18 2025
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000