NCT06843993

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2023

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 19, 2025

Last Update Submit

February 19, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Plasma concentration at end of infusion (Ceoi) of MK-2060

    Predose Day 1 and end of infusion

  • Plasma concentration at 168 hours (C168hr) of MK-2060

    At designated timepoints (up to 168 hours)

  • Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060

    At designated timepoints (up to 150 days)

  • AUC from 0 to 168 hours (AUC0-168) of MK-2060

    At designated timepoints (up to 168 hours)

  • Time to maximum observed plasma drug concentration (Tmax) of MK-2060

    At designated timepoints (up to 150 days)

  • +7 more secondary outcomes

Study Arms (4)

Panel A: MK-2060 Dose 1

EXPERIMENTAL

MK-2060 dose 1 was administered as a single intravenous (IV) infusion dose on Day 1.

Biological: MK-2060

Panel B: MK-2060 Dose 2

EXPERIMENTAL

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

Panel C: MK-2060 Dose 3

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo was administered as a single IV infusion over MK-2060-matched time period on Day 1.

Biological: Placebo

Interventions

MK-2060BIOLOGICAL

Single doses of MK-2060 administered via IV infusion on Day 1 according to randomization.

Panel A: MK-2060 Dose 1Panel B: MK-2060 Dose 2Panel C: MK-2060 Dose 3
PlaceboBIOLOGICAL

Single doses of placebo administered via IV infusion on Day 1 according to randomization.

Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Is in good health before randomization
  • Has a body mass index (BMI) ≥18 and ≤28 kg/m\^2.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 001)

Shanghai, Shanghai Municipality, 200032, China

Location

Related Links

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 25, 2025

Study Start

March 1, 2023

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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

More information

Locations

CN(1)