SHR-2173 injections for adults with primary immune thrombocytopenia.

A Phase I Study Evaluating the Safety, Efficacy, Pharmacokinetics and Pharmacokinetics of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia

This will test whether multiple subcutaneous injections of SHR-2173 are safe and well tolerated in adults with primary immune thrombocytopenia and low platelet counts.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07206758 on ClinicalTrials.gov

What this trial studies

This Phase I interventional trial administers multiple subcutaneous doses of SHR-2173 to adults with primary ITP to characterize safety and tolerability. Eligible participants must have primary ITP for at least 3 months, prior corticosteroid treatment, platelet counts <30×10⁹/L, WHO bleeding grade 0–1, and adequate organ function. The study is sponsored by Guangdong Hengrui Pharmaceutical and conducted at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology in Wuhan. Primary outcomes focus on adverse events, dose tolerability, and laboratory safety measures with scheduled follow-up visits.

Who should consider this trial

Good fit: Adults aged 18 or older with a confirmed diagnosis of primary ITP for ≥3 months, prior corticosteroid therapy, platelet count below 30×10⁹/L, WHO bleeding grade 0–1, and adequate organ function are the intended participants.

Not a fit: Patients with secondary causes of thrombocytopenia, uncontrolled or high-grade bleeding, significant organ dysfunction, or who cannot meet the contraceptive requirements are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, SHR-2173 could provide a new treatment option that improves platelet stability and reduces bleeding risk for adults with refractory primary ITP.

How similar studies have performed: While other subcutaneous agents such as thrombopoietin receptor agonists have improved platelet counts in ITP, SHR-2173 is a novel agent and has limited prior human data.

Eligibility criteria

Inclusion Criteria:

1. Participants must fully understand the trial content, procedures, and potential adverse reactions, and voluntarily sign a written informed consent form (ICF).
2. Age at signing the ICF must be ≥ 18 years (including the boundary value), regardless of gender.
3. Confirmed diagnosis of primary ITP for at least 3 months at screening.
4. Previous treatment with corticosteroids.
5. At the last ITP treatment, participants experienced loss of remission, no remission, relapse after remission, or intolerance.
6. Platelet count \<30×10⁹/L at screening with clinical assessment indicating treatment necessity
7. Participants must have adequate organ function
8. Clinically stable condition with World Health Organization (WHO) bleeding scale grade 0-1
9. 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 Criteria:

1. Diagnosis of secondary thrombocytopenia or concomitant autoimmune hemolytic anemia
2. 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
3. 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)
4. Previous treatment with SHR-2173
5. 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
6. History of any thrombotic or embolic events within 12 months prior to the first administration, or clinical symptoms and history suggesting thrombophilia
7. Current life-threatening bleeding (related to thrombocytopenia) or expected to require emergency treatment within one week after randomization
8. 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
9. 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
10. 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
11. 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)
12. Previous splenectomy
13. Previous allogeneic stem cell or organ transplantation (except for corneal transplantation ≥ 3 months prior to screening); known or suspected history of immunosuppression
14. Planned surgery during the dosing period
15. 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
16. 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)
17. Concurrent participation in other investigational studies within either 30 days prior to enrollment or 5 half-lives of the investigational drug (whichever is longer)
18. 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

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Junye Xiong

Conditions Immune Thrombocytopenia