MedDataX Logo

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.

NCT06916806 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-12

No results posted yet for this study

Summary

The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA

Study details include:

• The study duration will be a minimum of 180 days in addition to the screening period.

Additional follow-up visits may be required up to 12 months from study start.

* Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2).
* Study visits will occur at:

Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.

Conditions

  • Systemic Lupus Erythematosus
  • Idiopathic Inflammatory Myopathies
  • Rheumatoid Arthritis

Interventions

DRUG

AZD5492

IMP: subcutaneous.

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-06-22
Completion
2027-06-22
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • France
  • Germany
  • Japan
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

Related Clinical Trials

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06916806 on ClinicalTrials.gov