This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).
Participants who are of non-childbearing potential or are using acceptable contraception.
Body mass index (BMI) and body weight within an acceptable range.
Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments.
BMI and body weight within an acceptable range.
Pregnant or breastfeeding participants.
Recent vaccination within protocol-defined timelines.
Clinically significant medical history or abnormal physical examination findings.
Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead sponsor