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

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07649265
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • HBM7020 — DRUG
    Liquid formulation, administered through intravenous infusion

Study Details

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).

Key Dates

Start date
Sep 15, 2026
Status verified
Jun 2026
Primary completion
Nov 20, 2028
Completion
Nov 20, 2028

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Participants will receive HBM7020 in sequential dose-escalation cohorts in Part 1.
  • Experimental: Part 2
    Participants may receive optional retreatment of HBM7020 in Part 2 if eligible.

Primary Outcome Measure

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 ]

Central Contacts

Related Studies