Actively Recruiting
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
Led by Xencor, Inc. · Updated on 2026-05-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, how the body processes, and immune response to XmAb657 in healthy adults and adults with autoimmune diseases such as Idiopathic Inflammatory Myopathies, Systemic Sclerosis, and Sjogren's Disease. This is a Phase 1, first-in-human, open-label clinical trial evaluating the effects of XmAb657 given by injection under the skin. The study aims to better understand the potential effects of XmAb657 in these populations. Participants will receive XmAb657 as a subcutaneous injection in a dose-escalation format. The study includes healthy adults and adults diagnosed with specific autoimmune diseases based on established classification criteria. The treatment is administered under medical supervision, and dosing levels may increase over time to monitor safety and immune responses. During the study, participants will be monitored for any side effects or adverse reactions, including serious or treatment-emergent events, through week 52. Blood samples will be collected to measure the levels of XmAb657 and assess its effects on the immune system. The study involves regular visits for safety assessments and pharmacokinetic and pharmacodynamic evaluations. Participants may be involved for up to a year to ensure thorough monitoring.
CONDITIONS
Brief 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 the 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathy
- Adult participants meeting the 2013 ACR/EULAR Classification Criteria for Systemic Sclerosis
- Adult participants meeting the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome
- Use of highly effective methods of contraception for all participants
You will not qualify if you...
- Major surgery within 12 weeks prior to dosing or planned during the study
- Recurrent or active clinically significant infections
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive XmAb657 administered subcutaneously and are monitored for safety and response to treatment.
Trial Site Locations
Total: 1 location
1
Xencor Investigative Site
Melbourne, Australia
Actively Recruiting
Research Team
N
Noriko Iikuni, MD, PhD
J
Jaime Mertz
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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