A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body

Korábbi kezelés

• Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.

Más betegség

• Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
• Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.

Egyéb

• Pregnant or breastfeeding participants.
• Recent vaccination within protocol-defined timelines.
• Clinically significant medical history or abnormal physical examination findings.

• 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 2)
• 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 2)
• 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 2 disease-agnostic inclusion criteria.
• Stable background autoimmune therapy prior to dosing.
• Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.