A Phase 1 Open-Label, Multicenter Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HBM7020 in Healthy Adult Participants and Adults With Seropositive Autoimmune Disease
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.
∙ Key Disease-Agnostic Inclusion Criteria for Patient Participants (Part 1)
• BMI and body weight within an acceptable range.
• Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.
∙ Key Disease-Specific Inclusion Criteria for Patient Participants (Part 1)
• Confirmed autoimmune disease with appropriate supporting autoantibody findings.
• Stable background therapy prior to dosing.
• Active moderate to severe disease consistent with protocol-defined disease activity criteria for:
‣ Systemic lupus erythematosus (SLE)
⁃ Systemic sclerosis (SSc)
⁃ Rheumatoid arthritis (RA)
⁃ Sjögren's disease (SjD)
• Meets Part 1 disease-agnostic inclusion criteria.
• Stable background autoimmune therapy prior to dosing.
• Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.