Immune ThrombocytopeniaPhase 1NCT07206758
Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
A Phase 1 study testing SHR-2173 Injection in people with Immune Thrombocytopenia, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- SHR-2173 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2025to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zuxiang Jin contact
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Heng Mei
About this study
Official title: A Phase I Study Evaluating the Safety, Efficacy, Pharmacokinetics and Pharmacokinetics of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
- Conditions
- Immune Thrombocytopenia
- Being tested
- SHR-2173 Injection
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2173 InjectionDrug
SHR-2173 injection treatment
| Study group | Role | What they receive |
|---|---|---|
| SHR-2173 Injection | Experimental | Not described Receives: Drug: SHR-2173 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)
Measured: About in the ninth month
The severity of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI)
Measured: About in the ninth month
Changes in abnormal indicators in laboratory inspection
Measured: About in the ninth month
Secondary outcomes (12)
Percentage of subjects achieving remission response at week 13 of the treatment period
Measured: About in the fourth month
Percentage of subjects achieving remission response at week 25 of the treatment period
Measured: About in the sixth month
Percentage of participants achieving remission response at any time during the treatment period
Measured: About in the ninth month
Proportion of participants achieving confirmed remission after SHR-2173 injection treatment
Measured: About in the ninth month
Time from first SHR-2173 injection treatment to confirmed remission
Measured: About in the ninth month
Duration from first confirmed remission to date of remission loss
Measured: About in the ninth month
Number and severity of bleeding events
Measured: About in the ninth month
Percentage of participants requiring rescue therapy
Measured: About in the ninth month
Serum concentration of SHR-2173
Measured: About in the ninth month
Anti-SHR-2173 antibodies
Measured: About in the ninth month
Serum immunoglobulin levels
Measured: About in the ninth month
Count and percentage of B cells and subsets in peripheral blood
Measured: About in the ninth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start12 Nov 2025
- Primary completionJun 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206758
- Sponsor's protocol ID
- SHR-2173-105
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety, Efficacy, Pharmacokinetics and Pharmacokinetics of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07206758
- Acronym / sponsor ID
- SHR-2173-105
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-2173 Injection | Experimental | Drug: SHR-2173 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2173 InjectionSHR-2173 injection treatment | Drug | SHR-2173 Injection |
Primary outcome
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
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
Changes in abnormal indicators in laboratory inspection
Time frame: About in the ninth month
12 secondary outcomes
Percentage of subjects achieving remission response at week 13 of the treatment period
Time frame: About in the fourth month
Percentage of subjects achieving remission response at week 25 of the treatment period
Time frame: About in the sixth month
Percentage of participants achieving remission response at any time during the treatment period
Time frame: About in the ninth month
Proportion of participants achieving confirmed remission after SHR-2173 injection treatment
Time frame: About in the ninth month
Time from first SHR-2173 injection treatment to confirmed remission
Time frame: About in the ninth month
Duration from first confirmed remission to date of remission loss
Time frame: About in the ninth month
Number and severity of bleeding events
Time frame: About in the ninth month
Percentage of participants requiring rescue therapy
Time frame: About in the ninth month
Serum concentration of SHR-2173
Time frame: About in the ninth month
Anti-SHR-2173 antibodies
Time frame: About in the ninth month
Serum immunoglobulin levels
Time frame: About in the ninth month
Count and percentage of B cells and subsets in peripheral blood
Time frame: About in the ninth month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuxiang Jin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-2173 Injection in people with Immune Thrombocytopenia, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junye Xiong (0518-82342973, junye.xiong@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.