NCT07649265RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 24 Sept 2026
- Primary completion date
- 20 Nov 2028
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- NCT number
- NCT07649265
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 63
- From 24 Sept 2026 to the primary completion date, 20 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.
Other illness
- Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
- Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.
Other
- Pregnant or breastfeeding participants.
- Recent vaccination within protocol-defined timelines.
- Clinically significant medical history or abnormal physical examination findings.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Q-Pharm Pty Ltd Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.