NCT07306585
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
Not Yet Recruiting · Phase 1 · HC Biopharma Inc. · registry updated 2026-01-28
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- \. 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;
- \. Age ≥ 18 years, regardless of gender;
- \. 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;
- \. Patients diagnosed with SLE or CLE by the investigator
Exclusion
- \. active severe lupus nephritis
- \. active neuropsychiatric SLE
- 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;
- \. Drug-induced lupus;
- \. HIV medical history or positive test results, treponema pallidum antibody positive, hepatitis B infection (HBsAg or HBcAb positive), hepatitis C infection (HCV antibody positive and quantitative abnormality), cytomegalovirus infection (IgM positive and quantitative abnormality) and Epstein-Barr virus infection (IgM positive and quantitative abnormality);
- History of tuberculosis infection, or evidence of active or latent mycobacterium tuberculosis infection at the time of signing informed consent;