Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)

Part of paid clinical trials in Springfield, Missouri.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06575595
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Tulisokibart — BIOLOGICAL
    single dose via SC autoinjector (Treatment A) or concentration A or concentration B SC injection via syringe and vial (Treatments B and C)

Study Details

The primary objectives of the study are to characterize the pharmacokinetics (PK) of a single subcutaneous (SC) dose of tulisokibart (MK-7240) administered via autoinjector (AI) (Treatment A) and to characterize the PK of different concentrations of tulisokibart following SC administration of a single dose via vial/syringe (Treatments B and C). There is no formal hypothesis.

Key Dates

Start date
Sep 24, 2024
Status verified
Feb 2025
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    Single dose delivered subcutaneously (SC) with an autoinjector
  • Experimental: Treatment B
    Single dose of concentration A delivered SC with syringe and vial
  • Experimental: Treatment C
    Single dose of concentration B delivered SC with syringe and vial

Primary Outcome Measure

Area Under the Curve from Time 0 to Infinity (AUC0-inf): Treatment A [ Time Frame: Predose and Days 1, 2, 3, 4 ,5 ,6, 8, 10, 15, 29, 57, 71 and Post-study (Day 99) ]

Locations (1)

FacilityCityStateZIPSite coordinators
QPS Missouri ( Site 0003)SpringfieldMissouri65802-

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By research site
QPS Missouri· Springfield, MO

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