Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia

NCT07206758 | Recruiting Phase 1

• 1 other identifier: SHR-2173-105
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (3)

• The incidence of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)

  About in the ninth month

• The severity of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)

  About in the ninth month

• Changes in abnormal indicators in laboratory inspection

  About in the ninth month

Secondary Outcomes (12)

• 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

• Percentage of participants achieving remission response at any time during the treatment period

  About in the ninth month

• Proportion of participants achieving confirmed remission after SHR-2173 injection treatment

  About in the ninth month

• Time from first SHR-2173 injection treatment to confirmed remission

  About in the ninth month

Study Arms (1)

SHR-2173 Injection

EXPERIMENTAL

Drug: SHR-2173 Injection

Interventions

SHR-2173 Injection DRUG

SHR-2173 injection treatment

SHR-2173 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Junye Xiong

CONTACT

0518-82342973; junye.xiong@hengrui.com

Zuxiang Jin

CONTACT

zuxiang.jin@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-09

Locations

CN (1)