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.
Sequential
HBM7020
DrugLiquid formulation, administered through intravenous infusion
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48
Number of Participants With Signs Characteristic of Cytokine Release Syndrome (CRS), Immune Related Reaction (IRR), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Including Immunosuppression-Related Infection
Number of Participants With Dose limiting AE Evaluation During Dose Escalation
Number of Participants With Clinically Significant Changes in Vital Signs
Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of HBM7020
Maximum Observed Plasma Concentration (Cmax) of HBM7020
Time to Maximum Observed Plasma Concentration (tmax) of HBM7020
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