A Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Anima Diepenbeek ( Site 0601)
RECRUITING
Diepenbeek
Georgia
Arensia Exploartory Medicine ( Site 1301)
RECRUITING
Tbilisi
Italy
Istituto Clinico Humanitas- IRCCS ( Site 1902)
RECRUITING
Rozzano
Republic of Moldova
PMSI Republican Clinical Hospital T.Mosneaga ( Site 1001)
RECRUITING
Chisinau
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-02-19
Estimated Completion Date: 2029-07-16
Participants
Target number of participants: 21
Treatments
Experimental: Part 1 Prime Dose Escalation Panels
Participants will receive single intravenous (IV) doses of MK-1045 at varying dose levels.
Experimental: Part 2 Step-up Dose Escalation Panels
Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.
Experimental: Part 3 Dose Expansion Panels (Optional)
Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC