Systemic Lupus ErythematosusPhase 1NCT06955598
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus
A Phase 1 study testing SHR-2173 in people with Systemic Lupus Erythematosus, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- SHR-2173
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2024to 21 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, regardless of gender;
- Weight ≥45.0 kg at screening;
- Confirmed SLE diagnosis for ≥12 weeks at screening.
Who cannot join
- Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test.
- History of alcohol abuse or illegal drug use within one year prior to screening.
- Blood donation ≥450 mL within 8 weeks prior to screening or plans to donate blood during the study.
- Current active infection or a history of active tuberculosis
- Other inflammatory or autoimmune diseases beyond SLE and LN that may interfere with the interpretation of trial results or clinical assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital affiliated to Shanghai Jiaotong
Shanghai, Shanghai Municipality, 200000
About this study
To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- SHR-2173
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2173Drug
SHR-2173
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: | Experimental | SHR-2173 injection dose 1 Receives: Drug: SHR-2173 |
| Treatment group B: | Experimental | SHR-2173 injection dose 2 Receives: Drug: SHR-2173 |
| Treatment group C: | Experimental | SHR-2173 injection dose 3 Receives: Drug: SHR-2173 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Week 0~16
Secondary outcomes (3)
Cmax,
Measured: Week 0~16
AUC0-t,
Measured: Week 0~16
Anti- SHR -2173 antibody (ADA)
Measured: Week 0~16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start24 Nov 2024
- Primary completion10 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT06955598
- Sponsor's protocol ID
- SHR-2173-103
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06955598
- Acronym / sponsor ID
- SHR-2173-103
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 2 May 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.
To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: | Experimental | Drug: SHR-2173SHR-2173 injection dose 1 |
| Treatment group B: | Experimental | Drug: SHR-2173SHR-2173 injection dose 2 |
| Treatment group C: | Experimental | Drug: SHR-2173SHR-2173 injection dose 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years, regardless of gender;
- Weight ≥45.0 kg at screening;
- Confirmed SLE diagnosis for ≥12 weeks at screening.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test.
- History of alcohol abuse or illegal drug use within one year prior to screening.
- Blood donation ≥450 mL within 8 weeks prior to screening or plans to donate blood during the study.
- Current active infection or a history of active tuberculosis
- Other inflammatory or autoimmune diseases beyond SLE and LN that may interfere with the interpretation of trial results or clinical assessment.
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-2173SHR-2173 | Drug | Treatment group A:, Treatment group B:, Treatment group C: |
Primary outcome
Adverse events
Time frame: Week 0~16
3 secondary outcomes
Cmax,
Time frame: Week 0~16
AUC0-t,
Time frame: Week 0~16
Anti- SHR -2173 antibody (ADA)
Time frame: Week 0~16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Systemic Lupus Erythematosus, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 15 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Week 0~16). 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 15 Dec 2025.