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RecruitingPhase 1NCT07363590

A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)

◆ AI Clinical Summary

This study tests a new medicine called MK-1045 in people with lupus or rheumatoid arthritis. Researchers will give participants different amounts of the medicine to see how safe it is and how well people tolerate it. This is an early-stage study focused on understanding the medicine's safety.

Key Objective:The trial is testing whether MK-1045 is safe and well-tolerated at different dose levels in people with lupus or rheumatoid arthritis.

Who to Consider:People with systemic lupus erythematosus or rheumatoid arthritis who are interested in helping test a new experimental medicine should consider enrolling.

Trial Parameters

ConditionSystemic Lupus Erythematosus
SponsorMerck Sharp & Dohme LLC
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment21
SexALL
Min Age18 Years
Max Age75 Years
Start Date2026-02-19
Completion2029-07-16
Interventions
MK-1045

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Brief Summary

This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).

Eligibility Criteria

Inclusion Criteria: * Has a body mass index between 18 and 32 kg/m\^2, inclusive * Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) 2019 classification criteria * SLE: Is taking at least one background therapy for SLE * RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA Exclusion Criteria: * Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing * History of serious recurrent or chronic infection * Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus * Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB * Has a significant or uncontrolled medical disease in any organ

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