Actively Recruiting
Phase 1 Study to Assess Safety and Effects of XmAb657 Injection in Healthy Adults and Adults With Autoimmune Diseases Including Idiopathic Inflammatory Myopathies, Systemic Sclerosis, and Sjogrens Disease
Led by Xencor, Inc. · Updated on 2026-08-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying XmAb657 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy adults and adults with autoimmune diseases such as idiopathic inflammatory myopathies, systemic sclerosis, and Sjogrens disease. This Phase 1, first-in-human study aims to understand how the drug behaves in the body and its potential effects. Participants will receive XmAb657 by subcutaneous injection under the skin in a dose-escalation design. The study includes both healthy volunteers and individuals diagnosed with specific autoimmune diseases. The treatment phase involves administering XmAb657 and monitoring responses over time. During the study, participants will undergo various assessments including safety monitoring for treatment-emergent and serious adverse events, blood tests to measure drug concentration, and evaluations of pharmacodynamic effects. Researchers will track these outcomes through Week 52. Participants are expected to follow contraception requirements and attend scheduled visits for monitoring throughout the study duration.
CONDITIONS
Brief Title
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
Research Team
6
657-01 Study Information
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