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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07363590
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MK-1045 — BIOLOGICAL
    IV infusion

Study Details

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).

Key Dates

First listed
Jan 23, 2026
Start date
Feb 19, 2026
Status verified
Jul 2026
Primary completion
Jul 16, 2029
Completion
Jul 16, 2029

Study Design

Enrollment
21 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Part 1: Number of Participants with One or More Adverse Events (AEs) [ Time Frame: Up to approximately 12 weeks ]

Central Contacts

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Rheumatoid arthritis trialsLupus (SLE) trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

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