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

StatusRecruiting
PhasePhase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. to Otsuka Pharmaceutical Development & Commercialization, Inc.
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 15, 2026 to Sep 24, 2026
    • Eligibility criteria expanded, about 21 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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).
Trial Details
NCT Number NCT07649265
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions
(from sponsor)		 Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Sjögren's Disease
Related terms Arthritis, Rheumatoid, Autoimmune Diseases, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Sjogren's Syndrome
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov