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

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 Sjogrens 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.

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