Single Dose Study of Tulisokibart (MK-7240) in Healthy Chinese Participants (MK-7240-002)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06829225
Phase
PHASE1
Status
Completed

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Tulisokibart — DRUG
    SC Injection or IV Infusion
  • Placebo — DRUG
    Tulisokibart-matched Placebo SC Injection or IV Infusion

Study Details

The goal of this study is to learn about the safety of tulisokibart in healthy participants and what happens to tulisokibart over time when participants receive treatment intravenously versus subcutaneously.

Key Dates

Start date
Jun 13, 2024
Status verified
Feb 2025
Primary completion
Nov 11, 2024
Completion
Nov 11, 2024

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tulisokibart Dose 1 Treatment Subcutaneous (SC) Injection
    Participants will receive a single SC injection dose of tulisokibart at dose 1 on Day 1.
  • Placebo Comparator: Placebo SC Injection
    Participants will receive a single SC injection dose of placebo at on Day 1.
  • Experimental: Tulisokibart Dose 1 Intravenous (IV) Infusion
    Participants will receive a single IV infusion dose of tulisokibart at dose 1 on Day 1.
  • Experimental: Tulisokibart Dose 2 IV Infusion
    Participants will receive a single IV infusion dose of tulisokibart at dose 2 on Day 1.
  • Experimental: Tulisokibart Dose 3 IV Infusion
    Participants will receive a single IV infusion dose of tulisokibart at dose 3 on Day 1.
  • Placebo Comparator: Placebo IV Infusion
    Participants will receive a single IV infusion dose of placebo on Day 1.

Primary Outcome Measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to 99 Days ]

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