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

February 11, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-7240 in Healthy Chinese Participants.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital (Site 0001)

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:

Inclusion Criteria include, but are not limited to:

  • Be in good health
  • Has a body mass index (BMI) ≥18 and ≤28 kg/m^2 and weight ≥40.0 kg
  • Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the dosing of study drug

Exclusion Criteria:

Exclusion Criteria include, but are not limited to:

  • History of cancer (malignancy)
  • Has positive serum test for human immunodeficiency virus (HIV), hepatitis C or hepatitis B virus infection

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tulisokibart Dose 1 Treatment Subcutaneous (SC) Injection
Participants will receive a single SC injection dose of tulisokibart at dose 1 on Day 1.
Drug: Tulisokibart
SC Injection or IV Infusion
Other Names:
  • MK-7240
Placebo Comparator: Placebo SC Injection
Participants will receive a single SC injection dose of placebo at on Day 1.
Drug: Placebo
Tulisokibart-matched Placebo SC Injection or IV Infusion
Experimental: Tulisokibart Dose 1 Intravenous (IV) Infusion
Participants will receive a single IV infusion dose of tulisokibart at dose 1 on Day 1.
Drug: Tulisokibart
SC Injection or IV Infusion
Other Names:
  • MK-7240
Experimental: Tulisokibart Dose 2 IV Infusion
Participants will receive a single IV infusion dose of tulisokibart at dose 2 on Day 1.
Drug: Tulisokibart
SC Injection or IV Infusion
Other Names:
  • MK-7240
Experimental: Tulisokibart Dose 3 IV Infusion
Participants will receive a single IV infusion dose of tulisokibart at dose 3 on Day 1.
Drug: Tulisokibart
SC Injection or IV Infusion
Other Names:
  • MK-7240
Placebo Comparator: Placebo IV Infusion
Participants will receive a single IV infusion dose of placebo on Day 1.
Drug: Placebo
Tulisokibart-matched Placebo SC Injection or IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to 99 Days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Up to 99 Days
Number of Participants Who Discontinued the Study Due to AEs
Time Frame: Up to 99 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Up to 99 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Tulisokibart
Time Frame: Predose and at designated timepoints (up to 99 days postdose)
Blood samples will be collected to determine the AUC0-last of tulisokibart.
Predose and at designated timepoints (up to 99 days postdose)
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Tulisokibart
Time Frame: Predose and at designated timepoints (up to 99 days postdose)
Blood samples will be collected to determine the AUC0-inf of tulisokibart.
Predose and at designated timepoints (up to 99 days postdose)
Maximum Concentration (Cmax) of Tulisokibart
Time Frame: Predose and at designated timepoints (up to 99 days postdose)
Blood samples will be collected to determine the Cmax of tulisokibart.
Predose and at designated timepoints (up to 99 days postdose)
Time to Maximum Concentration (Tmax) of Tulisokibart
Time Frame: Predose and at designated timepoints (up to 99 days postdose)
Blood samples will be collected to determine the Tmax of tulisokibart.
Predose and at designated timepoints (up to 99 days postdose)
Apparent Terminal Half-life (t1/2) of Tulisokibart
Time Frame: Predose and at designated timepoints (up to 99 days postdose)
Blood samples will be collected to determine the t1/2 of tulisokibart.
Predose and at designated timepoints (up to 99 days postdose)
Apparent Clearance (CL/F) of Tulisokibart
Time Frame: Predose and at designated timepoints (up to 99 days postdose)
Blood samples will be collected to determine the CL/F of tulisokibart.
Predose and at designated timepoints (up to 99 days postdose)
Apparent Volume of Distribution (Vz/F) of Tulisokibart
Time Frame: Predose and at designated timepoints (up to 99 days postdose)
Blood samples will be collected to determine the Vz/F of tulisokibart.
Predose and at designated timepoints (up to 99 days postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Bioavailability Expressed as a Percentage (F%) of SC Tulisokibart
Time Frame: Predose and at designated timepoints (up to 99 days postdose)
Blood samples will be collected to determine the F% of tulisokibart.
Predose and at designated timepoints (up to 99 days postdose)

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)

June 13, 2024

Primary Completion (Actual)

November 11, 2024

Study Completion (Actual)

November 11, 2024

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-002
  • MK-7240-002 (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

product manufactured in and exported from the U.S.

Yes

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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