A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single Ascending Dose and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DB-2304 Injection in Healthy Adult Participants and Systemic Lupus Erythematosus Adult Participants
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single Ascending Dose and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DB-2304 Injection in Healthy Adults and Systemic Lupus Erythematosus Adult Participants
• Participants who fully understand the purpose, nature, method, and potential adverse reac-tions of the study and voluntarily sign the informed consent form (ICF) and agree to partic-ipate.
• 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.
• Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
• History or presence at Screening of positive antinuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.
• At screening have active lupus skin disease defined by the SELENA-SLEDAI at screening and randomization.
• Currently receiving a stable SLE treatment regimen of any medication (alone or in combi-nation) for a period of at least 1 month prior to randomization.