Rheumatoid ArthritisPhase 1NCT07649265
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
A Phase 1 study testing HBM7020 in people with Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis
- What is being tested?
- HBM7020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Sep 2026to 20 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
- Key Inclusion Criteria for Rescreening Participants (Part 2)
- 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.
Who cannot join
- Pregnant or breastfeeding participants.
- Recent vaccination within protocol-defined timelines.
- Clinically significant medical history or abnormal physical examination findings.
- Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
- Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.
- Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Q-Pharm Pty Ltd
Brisbane, Queensland, 4006
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Wong
About this study
Official title: 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).
- Being tested
- HBM7020
- Keywords
- Autoimmune disease
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Sjogren's Syndrome, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM7020Drug
Liquid formulation, administered through intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 and Part 2a Dose Escalation | Experimental | Healthy participants and participants with seropositive systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic sclerosis (SSc), or Sjögren's disease (SjD) will receive HBM7020 in sequential dose-escalation cohorts during Part 1 and Part 2a, respectively. Receives: Drug: HBM7020 |
| Part 2b | Experimental | Eligible patients may receive optional retreatment of HBM7020 in Part 2b Receives: Drug: HBM7020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48
Measured: Up to Week 48
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
Measured: Up to Week 24
Number of Participants With Dose limiting AE Evaluation During Dose Escalation
Measured: Up to Day 15
Number of Participants With Clinically Significant Changes in Vital Signs
Measured: Up to Week 24
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Measured: Up to Week 24
Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP)
Measured: Up to Week 20
Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR)
Measured: Up to Week 20
Change From Baseline in Serum Ferritin
Measured: Up to Week 20
Change From Baseline in Serum Immunoglobulin G (IgG)
Measured: Up to Week 20
Secondary outcomes (5)
Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020
Measured: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of HBM7020
Measured: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Maximum Observed Plasma Concentration (Cmax) of HBM7020
Measured: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Time to Maximum Observed Plasma Concentration (tmax) of HBM7020
Measured: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start24 Sep 2026
- Primary completion20 Nov 2028 (estimated)
- Study completion20 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649265
- Sponsor's protocol ID
- 365-201-00001
- Status last verified
- Nov 2026
- First submitted
- 11 Jun 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07649265
- Acronym / sponsor ID
- 365-201-00001
- Keywords
- Autoimmune disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 20 Nov 2028 (estimated)
- Study completion
- 20 Nov 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 and Part 2a Dose Escalation | Experimental | Drug: HBM7020Healthy participants and participants with seropositive systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic sclerosis (SSc), or Sjögren's disease (SjD) will receive HBM7020 in sequential dose-escalation cohorts during Part 1 and Part 2a, respectively. |
| Part 2b | Experimental | Drug: HBM7020Eligible patients may receive optional retreatment of HBM7020 in Part 2b |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding participants.
- Recent vaccination within protocol-defined timelines.
- Clinically significant medical history or abnormal physical examination findings.
- Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
- Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBM7020Liquid formulation, administered through intravenous infusion | Drug | Part 1 and Part 2a Dose Escalation, Part 2b |
Primary outcome
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48
Time frame: Up to Week 48
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
Time frame: Up to Week 24
Number of Participants With Dose limiting AE Evaluation During Dose Escalation
Time frame: Up to Day 15
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to Week 24
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Time frame: Up to Week 24
Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP)
Time frame: Up to Week 20
Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR)
Time frame: Up to Week 20
Change From Baseline in Serum Ferritin
Time frame: Up to Week 20
Change From Baseline in Serum Immunoglobulin G (IgG)
Time frame: Up to Week 20
5 secondary outcomes
Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of HBM7020
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Maximum Observed Plasma Concentration (Cmax) of HBM7020
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Time to Maximum Observed Plasma Concentration (tmax) of HBM7020
Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020
Time frame: Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Otsuka Clinical Trials websiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBM7020 in people with Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otsuka Call Center (844-687-3522, otsukaprofessionalservices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48 (time frame: Up to Week 48). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.