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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • SHR-2173 Injection

    Drug

    SHR-2173 injection treatment

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: SHR-2173 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
About in the ninth month
2

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

Time frame
About in the ninth month
3

Changes in abnormal indicators in laboratory inspection

Time frame
About in the ninth month

Secondary outcomes

1

Percentage of subjects achieving remission response at week 13 of the treatment period

Time frame
About in the fourth month
2

Percentage of subjects achieving remission response at week 25 of the treatment period

Time frame
About in the sixth month
3

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

Time frame
About in the ninth month
4

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

Time frame
About in the ninth month

Other outcomes

Sponsors and contacts

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