A Study of MK-2225 in Healthy Participants (MK-2225-003)

July 28, 2025 updated by: Merck Sharp & Dohme LLC

A Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-2225 in Healthy Participants

The purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to different doses of MK-2225 in a person's body over time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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

  • United States
    • Florida
      • Miami, Florida, United States, 33014-3616
        • Clinical Pharmacology of Miami (Site 0002)
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Bio-Kinetic Clinical Applications, LLC dba QPS-MO (Site 0004)

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 key inclusion criteria include but are not limited to the following:

  • Is in good health before randomization
  • Body Mass Index (BMI) ≤32 kg/m^2, inclusive

Exclusion Criteria:

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

  • History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • History of hypersensitivity to the MK-2225 drug substance, its inactive ingredients or the placebo (normal saline)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-2225 Panel A
Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks.
Drug: MK-2225
Subcutaneous administration
Experimental: MK-2225 Panel B
Participants receive MK-2225 Dose 2 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
Drug: MK-2225
Subcutaneous administration
Experimental: MK-2225 Panel C
Participants receive MK-2225 Dose 3 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
Drug: MK-2225
Subcutaneous administration
Experimental: MK-2225 Panel D
Participants receive MK-2225 Dose 4 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
Drug: MK-2225
Subcutaneous administration
Placebo Comparator: Placebo
Participants receive placebo SQ Q2W over the MK-2225-matched time period.
Other: Placebo
Subcutaneous administration

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 approximately 20 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. The number of participants who experience an AE will be reported.
Up to approximately 20 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 8 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. The number of participants who discontinue study/study treatment due to an AE will be reported.
Up to approximately 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of MK-2225
Time Frame: At designated timepoints (up to approximately 16 weeks)
Blood samples will be collected to determine the Cmax of MK-2225.
At designated timepoints (up to approximately 16 weeks)
Time to Maximum Plasma Concentration (Tmax) of MK-2225
Time Frame: At designated timepoints (up to approximately 16 weeks)
Blood samples will be collected to determine the Tmax of MK-2225.
At designated timepoints (up to approximately 16 weeks)
Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225
Time Frame: At designated timepoints (up to 16 approximately weeks)
Blood samples will be collected to determine the AUC0-τ of MK-2225.
At designated timepoints (up to 16 approximately weeks)
Apparent Terminal Half-life (t1/2) of MK-2225
Time Frame: At designated timepoints (up to approximately 16 weeks)
Blood samples will be collected to determine the t1/2 of MK-2225.
At designated timepoints (up to approximately 16 weeks)
Mean Accumulation Ratio of MK-2225
Time Frame: At designated timepoints (up to approximately 16 weeks)
Blood samples will be collected at designated timepoints to determine the mean accumulation ratio of MK-2225.
At designated timepoints (up to approximately 16 weeks)
Lowest Plasma Concentration (Ctrough) of MK-2225
Time Frame: At designated timepoints (up to approximately 16 weeks)
Blood samples will be collected to determine the Ctrough of MK-2225.
At designated timepoints (up to approximately 16 weeks)

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)

November 21, 2023

Primary Completion (Actual)

July 14, 2025

Study Completion (Actual)

July 14, 2025

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2225-003
  • MK-2225-003 (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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