A Study of MK-2060 in Healthy Participants (MK-2060-016)

May 16, 2025 updated by: Merck Sharp & Dohme LLC

A Single Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion and Intravenous Bolus Administration of MK-2060 in Healthy Participants

The goal of the study is to learn about the safety of MK-2060 and if people tolerate it when MK-2060 is given in different forms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

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, 33147
        • Advanced Pharma CR, LLC ( Site 0002)
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Alliance for Multispecialty Research, LLC ( 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:

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

  • Is in good health before randomization
  • Has a body mass index (BMI) between ≥18 and ≤32 kg/m^2, inclusive

Exclusion Criteria:

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

  • Has a 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
  • Has a history of cancer

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panel A: MK-2060 IV (20 minutes)
Participants will receive a single dose of MK-2060 via intravenous (IV) infusion over 20 minutes on Day 1.
Biological: MK-2060
Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization.
Experimental: Panel B: MK-2060 IV (10 minutes)
Participants will receive a single dose of MK-2060 via IV infusion over 10 minutes on Day 1.
Biological: MK-2060
Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization.
Experimental: Panel C: MK-2060 IV (5 minutes)
Participants will receive a single dose of MK-2060 via syringe over 5 minutes on Day 1.
Biological: MK-2060
Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization.
Experimental: Panel D: MK-2060 IV (2.5 minutes)
Participants will receive a single dose of MK-2060 via syringe over 2.5 minutes on Day 1.
Biological: MK-2060
Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization.
Experimental: Panel E: MK-2060 IV (1 minute)
Participants will receive a single dose of MK-2060 via syringe over 1 minute on Day 1.
Biological: MK-2060
Single doses of MK-2060 will be administered via IV infusion or syringe on Day 1 according to randomization.
Placebo Comparator: Placebo
Participants will receive a single dose of saline via IV infusion or syringe over MK-2060-matched time period on Day 1.
Biological: Placebo
Single doses of placebo will be administered via IV infusion or syringe on Day 1 according to randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With An Adverse Event (AE)
Time Frame: Up to 134 days
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants that experience an AE will be reported.
Up to 134 days
Number of Participants Discontinuing the Study Due to an AE
Time Frame: Up to 134 days
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants that discontinue the study due to an AE will be reported.
Up to 134 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC0-inf)
Time Frame: Predose and at designated time points post dose up to 120 days
Plasma samples will be collected at pre-specified time points pre- and post-dose to assess AUC0-inf.
Predose and at designated time points post dose up to 120 days
Maximum Observed Plasma Concentration (Cmax) of MK-2060
Time Frame: Predose and at designated time points post dose up to 120 days
Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Cmax.
Predose and at designated time points post dose up to 120 days
Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168)
Time Frame: Predose and at designated time points post dose up to 120 days
Plasma samples will be collected at pre-specified time points pre- and post-dose to assess AUC0-168 hours.
Predose and at designated time points post dose up to 120 days
Plasma Concentration of MK-2060 at 168 Hours (C168)
Time Frame: Predose and at designated time points post dose up to 120 days
Plasma samples will be collected at pre-specified time points pre- and post-dose to assess C168 hours.
Predose and at designated time points post dose up to 120 days
Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060
Time Frame: Predose and at designated time points post dose up to 120 days
Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Tmax.
Predose and at designated time points post dose up to 120 days
Plasma Elimination Terminal Half-life (t ½) of MK-2060
Time Frame: Predose and at designated time points post dose up to 120 days
Plasma samples will be collected at pre-specified time points pre- and post-dose to assess t½ .
Predose and at designated time points post dose up to 120 days
Apparent Oral Clearance (CL/F) of MK-2060
Time Frame: Predose and at designated time points post dose up to 120 days
Plasma samples will be collected at pre-specified time points pre- and post-dose to assess CL/F.
Predose and at designated time points post dose up to 120 days
Plasma Apparent Volume of Distribution (Vz/F) of MK-2060
Time Frame: Predose and at designated time points post dose up to 120 days
Plasma samples will be collected at pre-specified time points pre- and post-dose to assess Vz/F.
Predose and at designated time points post dose up to 120 days
Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060
Time Frame: Baseline and up to 120 days
Plasma samples will be collected at baseline and pre-specified time points post-dose to assess aPTT values. The fold change from baseline will be reported.
Baseline and up to 120 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)

October 15, 2024

Primary Completion (Actual)

April 18, 2025

Study Completion (Actual)

April 18, 2025

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2060-016
  • MK-2060-016 (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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