NCT07284797

A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Idiopathic Inflammatory Myopathy (IIM)

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 Idiopathic Inflammatory Myopathy

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with IIM. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.

Detailed description

This is a Phase 1 study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of XmAb657 in healthy adult participants and participants with IIM.

Conditions

• Healthy
• Idiopathic Inflammatory Myopathies

Interventions

Type	Name	Description
BIOLOGICAL	XmAb13676	Biological

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: Australia