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

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 Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus; Systemic Sclerosis; Sjögren's Disease
• Intervention / Treatment: Drug: HBM7020

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Otsuka Call Center; Phone Number: 844-687-3522; Email: otsukaprofessionalservices@otsuka-us.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 1)

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 1)

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 1 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; Participants will receive HBM7020 in sequential dose-escalation cohorts in Part 1.	Drug: HBM7020; Liquid formulation, administered through intravenous infusion
Experimental: Part 2; Participants may receive optional retreatment of HBM7020 in Part 2 if eligible.	Drug: HBM7020; Liquid formulation, administered through intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48	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	Up to Week 24
Number of Participants With Dose limiting AE Evaluation During Dose Escalation	Up to Day 15
Number of Participants With Clinically Significant Changes in Vital Signs	Up to Week 24
Number of Participants With Clinically Significant Changes in Physical Examination Findings	Up to Week 24
Change From Baseline in Serum Interleukin-6 (IL-6)	Up to Week 20
Change From Baseline in Serum Tumour Necrosis Factor-Alpha (TNF-α)	Up to Week 20
Change From Baseline in Serum Interferon-Gamma (IFN-γ)	Up to Week 20
Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP)	Up to Week 20
Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR)	Up to Week 20
Change From Baseline in Serum Ferritin	Up to Week 20
Change From Baseline in Serum Immunoglobulin G (IgG)	Up to Week 20

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020	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	Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Maximum Observed Plasma Concentration (Cmax) of HBM7020	Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Time to Maximum Observed Plasma Concentration (tmax) of HBM7020	Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)
Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020	Up to Week 24

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

Helpful Links

• Otsuka Clinical Trials website
• Otsuka Clinical Trial Transparency

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): November 20, 2028
• Study Completion (Estimated): November 20, 2028

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Autoimmune disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Immune System Diseases; Eye Diseases; Skin Diseases; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Sjogren's Syndrome; Autoimmune Diseases; Scleroderma, Systemic; Arthritis, Rheumatoid
• Other Study ID Numbers: 365-201-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No