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NCT Number: NCT07649265

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

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).

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria for Healthy Participants (Part 1)

  • 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)

Key Inclusion Criteria for Rescreening Participants (Part 2)

  • 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.

Key Exclusion Criteria for Parts 1 and 2

  • 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.

Treatment and study plan

HBM7020

Drug

Liquid formulation, administered through intravenous infusion

Primary outcomes

  1. 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

  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

    Time frame: Up to Week 24

  3. Number of Participants With Dose limiting AE Evaluation During Dose Escalation

    Time frame: Up to Day 15

  4. Number of Participants With Clinically Significant Changes in Vital Signs

    Time frame: Up to Week 24

  5. Number of Participants With Clinically Significant Changes in Physical Examination Findings

    Time frame: Up to Week 24

  6. Change From Baseline in Serum Interleukin-6 (IL-6)

    Time frame: Up to Week 20

  7. Change From Baseline in Serum Tumour Necrosis Factor-Alpha (TNF-α)

    Time frame: Up to Week 20

  8. Change From Baseline in Serum Interferon-Gamma (IFN-γ)

    Time frame: Up to Week 20

  9. Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP)

    Time frame: Up to Week 20

  10. Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR)

    Time frame: Up to Week 20

  11. Change From Baseline in Serum Ferritin

    Time frame: Up to Week 20

  12. Change From Baseline in Serum Immunoglobulin G (IgG)

    Time frame: Up to Week 20

Secondary outcomes

  1. 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)

  2. 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)

  3. Maximum Observed Plasma Concentration (Cmax) of HBM7020

    Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)

  4. Time to Maximum Observed Plasma Concentration (tmax) of HBM7020

    Time frame: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)

  5. Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020

    Time frame: Up to Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

Otsuka Call Center

CONTACT

[email protected]

844-687-3522

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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