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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06955598

Enrollment

Registered

2025-05-02

Start date

2024-11-24

Completion date

2025-11-21

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Brief 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).

Interventions

DRUGSHR-2173

SHR-2173

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Age 18-65 years, regardless of gender; 2. Weight ≥45.0 kg at screening; 3. Confirmed SLE diagnosis for ≥12 weeks at screening.

Exclusion criteria

1. Pregnant or breastfeeding women, or those with a positive human chorionic gonadotropin (HCG) test. 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.

Design outcomes

Primary

Measure	Time frame
Adverse events	Week 0~16

Secondary

Measure	Time frame
Cmax,	Week 0~16
AUC0-t,	Week 0~16
Anti- SHR -2173 antibody (ADA)	Week 0~16

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026