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

Sponsor ID
365-201-00001
Clinicaltrials.gov ID
NCT07649265
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-3522 or [email protected]
Will Be Recruiting
Sponsor ID
365-201-00001
Trial Details
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Age
18 - 75 Years
Therapeutic Area
  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Systemic Sclerosis
  • Sjögren's Disease
    • Sex
    Female & Male
    Trial Dates
    Sep 2026 - Nov 2028
    Healthy Volunteers
    Yes
    • 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.

    Study 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).

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: HBM7020
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    63
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Key Inclusion Criteria for Healthy Participants (Part 1)
    • 1. Participants who are of non-childbearing potential or are using acceptable contraception.

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • 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.

    Locations

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