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.

Part of paid clinical trials in Anniston, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06916806
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD5492 — DRUG
    IMP: subcutaneous.

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
May 2026
Primary completion
May 5, 2027
Completion
Sep 15, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Single Ascending Dose with AZD5492
    Participants will receive AZD5492 at an assigned dose as subcutaneous (SC) injection on Day 1.
  • Experimental: Part 2: Step-Up Dosing with AZD5492
    Participants will receive AZD5492 as SC injection at the priming dose determined in Part 1, on Day 1, and at a target dose, based on the emergent safety data, on Day 8.

Primary Outcome Measure

Safety evaluation of AZD5492: Number of participants with treatment-emergent adverse events. [ Time Frame: Day 1 to end of the study (up to 52 weeks) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteAnnistonAlabama36207-
Research SiteBirminghamAlabama35233-
Research SiteLa JollaCalifornia92037-
Research SiteSacramentoCalifornia95817-
Research SiteIowa CityIowa52242-
Research SiteOmahaNebraska68198-
Research SiteChapel HillNorth Carolina27599-

Find similar trials in Anniston, AL

By condition
Rheumatoid arthritisLupus (SLE)
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Research Site· Anniston, ALResearch Site· Birmingham, ALResearch Site· La Jolla, CAResearch Site· Sacramento, CAResearch Site· Iowa City, IAResearch Site· Omaha, NE

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