RecruitingPhase 1NCT07284797
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
A Phase 1, First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of XmAb657 in Healthy Participants and in Participants With Autoimmune Diseases
Sponsor
Xencor, Inc.
Enrollment
60 participants
Start Date
Feb 24, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- Healthy participants - Adult participants in good health
- Idiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)/American College of Rheumatology (ACR) Classification Criterion for IIM
- Systemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR/EULAR Classification Criteria for SSc
- Sjogren's Disease participants that meet the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome
- All participants - Use of highly effective methods of contraception
Exclusion Criteria5
- Major surgery within 12 weeks prior to dosing or planned within the study
- Recurrent infections or active clinically significant infection
- Active or untreated latent tuberculosis
- Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
- Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
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Interventions
BIOLOGICALXmAb657
Biological
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07284797
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