drugset / Trial / NCT07649265

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

NCT07649265 ↗

Phase 1 Not yet recruiting 63 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2026-09-15
Primary completion
2028-11-20
Completion
2028-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject HBM7020 Unknown — Intravenous