A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is T… (NCT07649265) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
63 participantsStarted 2026-09-15
Plain-language summary
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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. BMI and body weight within an acceptable range.
. Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.
. Confirmed autoimmune disease with appropriate supporting autoantibody findings.
. Stable background therapy prior to dosing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since HBM7020 is in Phase 1 and not yet recruiting, the primary goal is to establish safety rather than prove it works — so can you help me understand what that means for me personally, given that I already have an established autoimmune diagnosis like mine?
2The trial is specifically monitoring for serious immune reactions like cytokine release syndrome and a neurological condition called ICANS — how concerned should I be about these risks, and how do they compare to the risks of treatments I might already be considering?
3The study involves dose escalation over what could be up to 48 weeks of follow-up — how would participating in a trial this long fit with managing my current condition, and would I still have access to my standard treatments if my symptoms worsen during the study?
4The trial is tracking changes in inflammatory markers like IL-6, TNF-α, and C-reactive protein — does my current disease activity or any medications I'm already on affect whether it would even be meaningful for me to take part?
5Since this trial hasn't started recruiting yet, what should I be doing in the meantime to keep my treatment options open, and is there an established standard-of-care approach for my specific condition that might make more sense to try first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48
Timeframe: Up to Week 48
2
Number of Participants With Signs Characteristic of Cytokine Release Syndrome (CRS), Immune Related Reaction (IRR), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Including Immunosuppression-Related Infection
Timeframe: Up to Week 24
3
Number of Participants With Dose limiting AE Evaluation During Dose Escalation
Timeframe: Up to Day 15
4
Number of Participants With Clinically Significant Changes in Vital Signs
Timeframe: Up to Week 24
5
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Timeframe: Up to Week 24
6
Change From Baseline in Serum Interleukin-6 (IL-6)
Timeframe: Up to Week 20
7
Trial details
NCT IDNCT07649265
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.