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Clinical Trials in Australia / NCT07284797
Recruiting Phase 1

A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases

NCT07284797 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2026-02-24
Last updated
2026-08-03

Condition(s) studied

HealthyIdiopathic Inflammatory MyopathiesSystemic SclerosisSjögren's Disease

Investigational drug(s) / intervention(s)

XmAb657

XmAb657: Biological

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: 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 Criteria: * 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 Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xencor Investigative Site Melbourne Australia Recruiting

More Xencor, Inc. trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284797 on ClinicalTrials.gov ↗ ← All trials in Australia