A Study of MK-7240 in Healthy Participants (MK-7240-009)

April 2, 2026 updated by: Merck Sharp & Dohme LLC

A Randomized, Open-label, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Tulisokibart Delivered by 2 Different Autoinjectors in Healthy Participants

The goal of this study is to learn what happens to MK-7240 in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of MK-7240 and if people tolerate it.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • Recruiting
        • Nucleus Network ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: +61737072720
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Nucleus Network ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: +6138593 9801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

  • Has a body-mass index (BMI) between 18 and 32 kg/m^2

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

  • Has a history of more than 1 episode of herpes zoster infection or history of disseminated herpes zoster infection
  • Has a history of or current active tuberculosis (TB) infection or history of latent TB that was not fully treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Tulisokibart Form 1
Participants will receive tulisokibart form 1.
Biological: Tulisokibart Form 1
Solution for injection.
Other Names:
  • MK-7240
Experimental: Arm 2: Tulisokibart Form 2
Participants will receive tulisokibart form 2.
Biological: Tulisokibart Form 2
Solution for injection.
Other Names:
  • MK-7240

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the AUC0-inf of tulisokibart.
At designated timepoints up to 14 weeks
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the AUC0-last of tulisokibart.
At designated timepoints up to 14 weeks
Maximum Plasma Concentration (Cmax) of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the Cmax of tulisokibart.
At designated timepoints up to 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: At designated timepoints up to 14 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
At designated timepoints up to 14 weeks
Number of Participants Who Discontinue Study Due to an AE
Time Frame: At designated timepoints up to 14 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
At designated timepoints up to 14 weeks
Time to Maximum Plasma Concentration (Tmax) of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the Tmax of tulisokibart.
At designated timepoints up to 14 weeks
Apparent Clearance (CL/F) of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the CL/F of tulisokibart.
At designated timepoints up to 14 weeks
Apparent Volume of Distribution (V/F) of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the V/F of tulisokibart.
At designated timepoints up to 14 weeks
Apparent Terminal Half-life (t1/2) of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the t1/2 of tulisokibart.
At designated timepoints up to 14 weeks
Apparent Terminal Elimination Rate constant (Kel) of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the Kel of tulisokibart.
At designated timepoints up to 14 weeks
Ratio of AUC0-Last/AUC0-Inf of Tulisokibart
Time Frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the ratio of AUC0-last/AUC0-inf of tulisokibart.
At designated timepoints up to 14 weeks
Area Under the Concentration-Time Curve from Time 0 to Day 14 (pAUC0-14) of Tulisokibart
Time Frame: At designated timepoints up to 14 days
Blood samples will be collected to determine pAUC0-14 of tulisokibart.
At designated timepoints up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Estimated)

September 3, 2026

Study Completion (Estimated)

September 3, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 7240-009
  • MK-7240-009 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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