Tests HBM7020 in healthy adults and adults with autoimmune diseases such as lupus
Tests how safe HBM7020 is in healthy adults and people with autoimmune diseases.
Plain-language title generated from the registry record
Registry title: A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Key facts
- Where
- Brisbane, AustraliaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07649265, who can take part
Where in Australia
- Q-Pharm Pty LtdBrisbane, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Trial code
- NCT07649265
- Record updated
- 5 November 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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.
Exclusion: Prior or recent therapies or conditions that may interfere with study participation or safety evaluations; Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings; Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension; Pregnant or breastfeeding participants; Recent vaccination within protocol-defined timelines; Clinically significant medical history or abnormal physical examination findings.