A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body

NCT07649265 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 365-201-00001
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Rheumatoid Arthritis; Systemic Lupus Erythematosus; Systemic Sclerosis; Sjögren's Disease

Keywords

Autoimmune disease

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (5)

• 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

Study Arms (2)

Part 1

EXPERIMENTAL

Participants will receive HBM7020 in sequential dose-escalation cohorts in Part 1.

Drug: HBM7020

Part 2

EXPERIMENTAL

Participants may receive optional retreatment of HBM7020 in Part 2 if eligible.

Drug: HBM7020

Interventions

HBM7020 DRUG

Liquid formulation, administered through intravenous infusion

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• Stable background autoimmune therapy prior to dosing.
• Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Related Links

• Otsuka Clinical Trials website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Sjogren's Syndrome; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Skin Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Otsuka Call Center

CONTACT

844-687-3522; otsukaprofessionalservices@otsuka-us.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): November 20, 2028
• Study Completion (Estimated): November 20, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/