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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: SHR-2173

Study type: Interventional

Funder types: Industry

Identifiers

NCT06955598

SHR-2173-103

Details and patient eligibility

About

To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Treatment group A:

Experimental group

Description:

SHR-2173 injection dose 1

Treatment:

Drug: SHR-2173

Treatment group B:

Experimental group

Description:

SHR-2173 injection dose 2

Treatment:

Drug: SHR-2173

Treatment group C:

Experimental group

Description:

SHR-2173 injection dose 3

Treatment:

Drug: SHR-2173