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
NCT ID: NCT06955598
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2024-11-24
2025-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group A:
SHR-2173 injection dose 1
SHR-2173
SHR-2173
Treatment group B:
SHR-2173 injection dose 2
SHR-2173
SHR-2173
Treatment group C:
SHR-2173 injection dose 3
SHR-2173
SHR-2173
Interventions
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SHR-2173
SHR-2173
Eligibility Criteria
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Inclusion Criteria
2. Weight ≥45.0 kg at screening;
3. Confirmed SLE diagnosis for ≥12 weeks at screening.
Exclusion Criteria
2. History of alcohol abuse or illegal drug use within one year prior to screening.
3. Blood donation ≥450 mL within 8 weeks prior to screening or plans to donate blood during the study.
4. Current active infection or a history of active tuberculosis
5. Other inflammatory or autoimmune diseases beyond SLE and LN that may interfere with the interpretation of trial results or clinical assessment.
18 Years
65 Years
ALL
No
Sponsors
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Guangdong Hengrui Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Renji Hospital affiliated to Shanghai Jiaotong
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SHR-2173-103
Identifier Type: -
Identifier Source: org_study_id
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