A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
- Sponsor
- Xencor, Inc.
- Study ID
- NCT07284797
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Healthy
- Idiopathic Inflammatory Myopathies
- Sjögren's Disease
- Systemic Sclerosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- XmAb657 — BIOLOGICALBiological
Study Details
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.
Key Dates
- Start date
- Feb 24, 2026
- Status verified
- May 2026
- Primary completion
- Oct 31, 2028
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose EscalationXmAb657 administered SC
Primary Outcome Measure
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Through Week 52 ]
Central Contacts
- Noriko Iikuni, MD, PhD
- Jaime Mertz
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