A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
NCT07284797 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-22
Summary
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.
Conditions
- Healthy
- Idiopathic Inflammatory Myopathies
- Systemic Sclerosis
- Sjögren's Disease
Interventions
- BIOLOGICAL
-
XmAb657
Biological
Sponsors & Collaborators
-
Xencor, Inc.
lead INDUSTRY
Principal Investigators
-
Mark Osterman, MD, MSCE · Xencor, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-24
- Primary Completion
- 2028-10-31
- Completion
- 2028-10-31
Countries
- Australia
Study Locations
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