The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE/CLE subjects. Secondary objectives of study are as follows: To estimate the PK parameters of multiple-ascending SC doses of HC022 in SLE/CLE subjects；To evaluate the immunogenicity of HC022 administered to SLE/CLE subjects.
1. Subjects who voluntarily participate in the study, are able to sign the informed consent form and comply with the requirements on the informed consent form;
2. Age ≥ 18 years, regardless of gender;
3. Subjects and their partners have no birth plan during the study treatment period and within 6 months after the last dose, and voluntarily use effective and reliable contraception (Attachment 1). Female subjects must have a negative serum pregnancy test and be non-lactating;
4. Patients diagnosed with SLE or CLE by the investigator
1. active severe lupus nephritis
2. active neuropsychiatric SLE
3 .History or current diagnosis of any other systemic autoimmune disease other than secondary Sjogren's syndrome, including but not limited to rheumatoid arthritis, psoriatic arthritis, dermatomyositis, systemic sclerosis (scleroderma), clinically significant non-SLE related vasculitis;
4. Drug-induced lupus;
Parallel
HC022
DrugAdministered as specified in the treatment arm
Placebo
DrugAdministered as specified in the treatment arm
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Cmax of HC022
Terminal Elimination Half-Life (t1/2) of HC022
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