Systemic Lupus Erythematosus (SLE) Clinical Trials

⁃ Participants who fully understand the purpose, nature, method, and potential adverse reactions of the study and voluntarily sign the informed consent form (ICF) and agree to participate.

⁃ Healthy male or female participants; 18 to 55 years of age (both inclusive) on the day of signing ICF; meet the body mass index (BMI) criteria.

⁃ Based on the investigator assessment, there are no abnormal findings or findings with clinical significance from the medical history consultation, physical examination, vital signs assessment, clinical laboratory tests, and 12-lead ECG.

⁃ Female participants of childbearing potential or male participants agree to use highly effective contraception during the study.

⁃ Participants who are willing and able to comply with the prescribed protocol treatment and evaluations

⁃ Participants who fully understand the purpose, nature, method, and potential adverse reactions of the study and voluntarily sign the informed consent form (ICF) and agree to participate.

⁃ Participants who are willing and able to comply with the prescribed protocol treatment and evaluations.

⁃ Male or female participants, 18 to 70 years of age (both inclusive) on the day of signing ICF.

⁃ Currently receiving a stable SLE/CLE treatment regimen of any medication for a period of at least 1 month prior to randomization.

‣ For SLE： 4. Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.

‣ 5\. History or presence at Screening of positive antinuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.

‣ 6\. At screening have active lupus skin disease defined by the SELENA-SLEDAI at screening and randomization.

‣ For CLE： 8. Must have diagnosis of CLE that has been histologically confirmed, with or without systemic LE manifestations.

• Must have active CLE despite an adequate trial of conventional therapies.