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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • XmAb657 — BIOLOGICAL
    Biological

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 Escalation
    XmAb657 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

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