Test of HBM7020 in healthy adults and adults with autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human trial evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. It starts with healthy participants at low doses, then includes adults with moderate to severe autoimmune diseases characterized by B-cell involvement. Eligible diseases include systemic lupus erythematosus, systemic sclerosis, Sjögren's disease, and rheumatoid arthritis. The study uses disease-appropriate activity criteria and maintains stable background therapy for patient participants. The investigation is led by Otsuka with Q-Pharm as the site in Brisbane, Australia.

Why it matters

Who can join: the full rules

Key Inclusion Criteria for Healthy Participants (Part 1)

1. Participants who are of non-childbearing potential or are using acceptable contraception.
2. Body mass index (BMI) and body weight within an acceptable range.
3. Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments.

Key Disease-Agnostic Inclusion Criteria for Patient Participants (Part 2)

1. BMI and body weight within an acceptable range.
2. Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.

Key Disease-Specific Inclusion Criteria for Patient Participants (Part 2)

1. Confirmed autoimmune disease with appropriate supporting autoantibody findings.
2. Stable background therapy prior to dosing.
3. 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)

Key Inclusion Criteria for Rescreening Participants (Part 2)

1. Meets Part 2 disease-agnostic inclusion criteria.
2. Stable background autoimmune therapy prior to dosing.
3. Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.

Key Exclusion Criteria for Parts 1 and 2

1. Pregnant or breastfeeding participants.
2. Recent vaccination within protocol-defined timelines.
3. Clinically significant medical history or abnormal physical examination findings.
4. Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
5. Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.
6. Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.

Where it's running

• Q-Pharm Pty Ltd
  Brisbane, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Otsuka Call Center
• Email: otsukaprofessionalservices@otsuka-us.com
• Phone: 844-687-3522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.