A Phase I Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of CC312 in Patients With Moderate-to-Severe Systemic Lupus Erythematosus
This study is a randomized, double-blind, placebo-controlled Phase I clinical trial featuring single and multiple ascending doses. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of CC312 in adult patients with moderate to severe systemic lupus erythematosus (SLE).
• Fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
• Aged 18 to 65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.
• Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria.
• SLEDAI-2000 score ≥7 with at least one BILAG A or two BILAG B domains, despite standard therapy.
• Meet at least one of the following criteria: positive antinuclear antibody (ANA) ≥1:80 at screening, positive anti-dsDNA antibody at screening, or positive anti-Sm antibody at screening.
• Have had an inadequate response to at least two standard therapies (e.g., corticosteroids, antimalarials, immunosuppressants, biologics) prior to screening, including at least one immunosuppressant and/or biologic. Prior to the first dose, subjects must have been on a stable dose of corticosteroids (e.g., ≤40 mg/day prednisone or equivalent at screening and during the screening period; if used alone, ≥7.5 mg/day prednisone or equivalent) and/or antimalarials and/or immunosuppressants for at least 12 weeks, with doses stable for ≥30 days.
• Females of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose and refrain from oocyte collection or donation during this period. Their male partners of childbearing potential must also use effective contraception.
• Males of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose, with no plans for fertility or sperm donation. Their female partners of childbearing potential must also use effective contraception during this period.