Safety of XmAb657 in Healthy Adults and People With Autoimmune Diseases
Tests the safety of XmAb657 in healthy adults and people with autoimmune disease.
Plain-language title generated from the registry record
Registry title: A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
Key facts
- Where
- Melbourne, AustraliaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07284797, who can take part
Where in Australia
- MelbourneMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xencor, Inc.
- Trial code
- NCT07284797
- Record updated
- 3 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.