Actively Recruiting
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
Led by Xencor, Inc. · Updated on 2026-05-12
60
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants in good health (healthy group)
- Adult participants meeting 2017 EULAR/ACR criteria for idiopathic inflammatory myopathy
- Adult participants meeting 2013 ACR/EULAR criteria for systemic sclerosis
- Adult participants meeting 2016 ACR/EULAR criteria for primary Sjogren's syndrome
- Use of highly effective contraception methods
You will not qualify if you...
- Major surgery within 12 weeks before dosing or planned during the study
- Recurrent or active significant infections
- Active or untreated latent tuberculosis
- Cancer or lymphoproliferative disease within the past 5 years
- Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xencor Investigative Site
Melbourne, Australia
Actively Recruiting
Research Team
N
Noriko Iikuni, MD, PhD
CONTACT
J
Jaime Mertz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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