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.
Start Date
5/1/2025
Completion Date
9/15/2027
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.
Detailed Description
This is an open-label, multi-centre Phase I study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD5492 in adult participants with either SLE or IIM or RA. The study consists of 2 parts: Part 1 - Single ascending dose (SAD) Part 1 will be a sequential SAD design in adult participants with SLE. Up to 5 dose levels of AZD5492 are planned to be investigated. Depending on emerging data, up to 4 additional dose levels may be added at the discretion of the Sponsor. The decision to open Part 2 will be made by the Safety Review Committee (SRC) based on the evaluation of all available data including safety, tolerability, PK, and PD from Part 1 and pertinent data arising from other ongoing studies with AZD5492 will also be considered, and the dose levels and dosing strategy for Part 2 will be confirmed. After a screening period of up to 42 days, participants will receive 1 dose of AZD5492 and be followed up for at least 179 days post-dose. Part 2 - Step-up dosing (SUD) Part 2 will be a SUD design in adult participants who have SLE (and did not participate in Part 1), as well as adult participants with IIM or RA. In Part 2, participants will receive 2 dose administrations, 7 days apart. The first (priming) dose of the step-up regimen will be agreed by the SRC. The second (target) dose will be escalated, and a minimum of 3 target dose levels are planned to be investigated in Part 2.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
AZD5492
Conditions
Locations
Research Site
Anniston, Alabama 36207
United States
Research Site
Birmingham, Alabama 35233
United States
Research Site
La Jolla, California 92037
United States
Research Site
Sacramento, California 95817
United States
Research Site
Iowa City, Iowa 52242
United States
Research Site
Omaha, Nebraska 68198
United States
Research Site
Chapel Hill, North Carolina 27599
United States
Research Site
Hamilton, Ontario L8S 4K1
Canada
Research Site
Sherbrooke, Quebec J1G 2E8
Canada
Research Site
Beijing, 100730
China
Research Site
Shanghai, 200001
China
Research Site
Wuhan, 430022
China
Research Site
Zhengzhou, 450052
China
Research Site
Bordeaux, 33000
France
Research Site
Montpellier, 34295
France
Research Site
Nancy, 54035
France
Research Site
Paris, 75013
France
Research Site
Strasbourg, 67098
France
Research Site
Toulouse, 31059
France
Research Site
Cologne, 50937
Germany
Research Site
Erlangen, 91054
Germany
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Magdeburg, 39120
Germany
Research Site
Pok Fu Lam, 999077
Hong Kong
Research Site
Bunkyō City, 113-8655
Japan
Research Site
Kita-gun, 761-0793
Japan
Research Site
Kitakyushu-shi, 807-8555
Japan
Research Site
Kyoto, 606-8501
Japan
Research Site
Nagasaki, 852-8501
Japan
Research Site
Amsterdam, 1105 AZ
Netherlands
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Leiden, 2333
Netherlands
Research Site
Mérida, 06800
Spain
Research Site
Seville, 41010
Spain
Research Site
Valladolid, 47012
Spain
Research Site
Glasgow, G31 2ER
United Kingdom
Research Site
London, SE5 9RS
United Kingdom
Research Site
London, WC1E 6JF
United Kingdom
Research Site
Southampton, SO16 6YD
United Kingdom