Phase I Study of AZD5492 Given by Injection to Adults With Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, or Rheumatoid Arthritis to Assess Safety and How the Drug Works in the Body

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of AZD5492, a drug given by subcutaneous injection, in adults diagnosed with Systemic Lupus Erythematosus SLE, Idiopathic Inflammatory Myopathies IIM, or Rheumatoid Arthritis RA. This open-label, multi-center Phase I study is designed to understand how the drug behaves in the body and its safety profile in these autoimmune conditions. The study is sponsored by AstraZeneca and includes adult participants between 18 and 70 years old. The study has two parts. In Part 1, participants with SLE receive a single dose of AZD5492 at ascending dose levels to evaluate safety and dosing. Up to five dose levels are planned, with the possibility of additional doses based on emerging data. In Part 2, participants with SLE not in Part 1, IIM, or RA receive two doses of AZD5492 seven days apart in a step-up dosing pattern, starting with a priming dose followed by an escalated target dose. Study visits are scheduled at screening, several early days after dosing, and then periodically through Day 180. Participants will be involved in visits for screening, dosing, and follow-up assessments lasting at least 180 days after dosing, with possible additional visits up to 12 months from study start. Researchers will monitor safety by tracking treatment-emergent adverse events, dose-limiting toxicities, laboratory and vital sign abnormalities, and heart monitoring via ECG. They will also measure drug levels in the blood, immune responses, and changes in B-cell counts to better understand how AZD5492 works and its effects over time.

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.