A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMerck Sharp & Dohme LLC
About this trial
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
Qualifiers
Has a body mass index between 18 and 32 kg/m², 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- MK-1045
Treatment groups
21 Participants
are divided into 3 treatment groupsLocations
17Australia
Gold Coast University Hospital ( Site 1601)4215, SouthportQueensland, Australia
Belgium
Anima Diepenbeek ( Site 0601)3590, DiepenbeekLimburg, Belgium
UZ Gent ( Site 0602)9000, GhentOost-Vlaanderen, Belgium
China
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)100005, BeijingBeijing Municipality, China
Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Source ClinicalTrials.gov