Single-Ascending Dose Study of MK-2060 in Healthy Chinese Male Adult Participants (MK-2060-009)

A Single-Ascending Dose Clinical Trial to Study the Safety, Pharmacokinetics and Pharmacodynamics of MK-2060 in Healthy Chinese Male Adult Participants

The goal of the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: MK-2060; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 001)

Participation Criteria

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) ≥18 and ≤28 kg/m^2.

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 (malignancy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A: MK-2060 Dose 1; MK-2060 dose 1 was administered as a single intravenous (IV) infusion dose on Day 1.	Biological: MK-2060; Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization.
Experimental: Panel B: MK-2060 Dose 2; MK-2060 dose 2 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel A and B.	Biological: MK-2060; Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization.
Experimental: Panel C: MK-2060 Dose 3; MK-2060 dose 3 was administered as a single IV infusion dose on Day 1. There was at least a 21-day period between dosing in Panel B and C.	Biological: MK-2060; Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization.
Placebo Comparator: Placebo; Placebo was administered as a single IV infusion over MK-2060-matched time period on Day 1.	Biological: Placebo; Single doses of placebo administered via IV infusion on Day 1 according to randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who experience one or more adverse events (AEs)	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.	Up to 164 days
Number of participants who discontinue study due to an AE	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.	Up to 164 days
Number of participants who experience one or more AEs related to bleeding	A bleeding related AE includes any sign or symptom of bleeding even if not requiring intervention by a medical/ healthcare professional, to clinically-relevant non major bleeding or major bleeding.	Up to 164 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration at end of infusion (Ceoi) of MK-2060	Ceoi is defined as the amount of MK-2060 in plasma following IV infusion administration of MK-2060. Blood samples were collected at pre-specified time points to assess Ceoi.	Predose Day 1 and end of infusion
Plasma concentration at 168 hours (C168hr) of MK-2060	C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose. Blood samples were collected at pre-specified time points to assess C168hr.	At designated timepoints (up to 168 hours)
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060	AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity. Blood samples were collected at pre-specified time points to assess AUC0-inf.	At designated timepoints (up to 150 days)
AUC from 0 to 168 hours (AUC0-168) of MK-2060	AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours. Blood samples were collected at pre-specified time points to assess AUC0-168.	At designated timepoints (up to 168 hours)
Time to maximum observed plasma drug concentration (Tmax) of MK-2060	Tmax is defined as time to the maximum concentration of MK-2060 reached. Blood samples were collected at pre-specified time points to assess Tmax.	At designated timepoints (up to 150 days)
Terminal half-life of MK-2060	t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060. Blood samples were collected at pre-specified time points to assess terminal half-life.	At designated timepoints (up to 150 days)
Clearance (CL) of MK-2060	CL is the volume of plasma from which MK-2060 is completely removed per unit time. Blood samples were collected at pre-specified time points to assess CL.	At designated timepoints (up to 150 days)
Volume of distribution (Vz) of MK-2060	Vz is defined as the distributed volume of MK-2060 in plasma. Blood samples were collected at pre-specified time points to assess Vz.	At designated timepoints (up to 150 days)
Change from baseline in activated partial thromboplastin time (aPTT)	Blood samples were collected at pre-specified time points to assess change from baseline in aPTT.	Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days)
Anti-drug antibodies (ADA) positive incidence	Blood samples were collected at pre-specified time points to assess the incidence of anti-MK-2060 antibodies.	At designated timepoints (up to 150 days)
Factor XI (FXI) activity level	Blood samples were collected at pre-specified time points to assess FXI activity level.	At designated timepoints (up to 150 days)
Prothrombin time (PT)	Blood samples were collected at pre-specified time points to assess PT.	At designated timepoints (up to 150 days)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 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 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2060-009; MK-2060-009 (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
• product manufactured in and exported from the U.S.: Yes