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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SHR-2173 Injection

Treatment groups

10 Participants
are divided into 1 treatment group