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

NCT06582602 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2060-016MK-2060-016
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With An Adverse Event (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. 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

  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 Outcomes (9)

• Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC0-inf)

  Predose and at designated time points post dose up to 120 days

• Maximum Observed Plasma Concentration (Cmax) of MK-2060

  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)

  Predose and at designated time points post dose up to 120 days

• Plasma Concentration of MK-2060 at 168 Hours (C168)

  Predose and at designated time points post dose up to 120 days

• Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060

  Predose and at designated time points post dose up to 120 days

Study Arms (6)

Panel A: MK-2060 IV (20 minutes)

EXPERIMENTAL

Participants will receive a single dose of MK-2060 via intravenous (IV) infusion over 20 minutes on Day 1.

Biological: MK-2060

Panel B: MK-2060 IV (10 minutes)

EXPERIMENTAL

Participants will receive a single dose of MK-2060 via IV infusion over 10 minutes on Day 1.

Biological: MK-2060

Panel C: MK-2060 IV (5 minutes)

EXPERIMENTAL

Participants will receive a single dose of MK-2060 via syringe over 5 minutes on Day 1.

Biological: MK-2060

Panel D: MK-2060 IV (2.5 minutes)

EXPERIMENTAL

Participants will receive a single dose of MK-2060 via syringe over 2.5 minutes on Day 1.

Biological: MK-2060

Panel E: MK-2060 IV (1 minute)

EXPERIMENTAL

Participants will receive a single dose of MK-2060 via syringe over 1 minute on Day 1.

Biological: MK-2060

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of saline via IV infusion or syringe over MK-2060-matched time period on Day 1.

Biological: Placebo

Interventions

MK-2060 BIOLOGICAL

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

Panel A: MK-2060 IV (20 minutes); Panel B: MK-2060 IV (10 minutes); Panel C: MK-2060 IV (5 minutes); Panel D: MK-2060 IV (2.5 minutes); Panel E: MK-2060 IV (1 minute)

Placebo BIOLOGICAL

Single doses of placebo will be administered via IV infusion or syringe on Day 1 according to randomization.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

Advanced Pharma CR, LLC ( Site 0002)

Miami, Florida, 33147, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0001)

Knoxville, Tennessee, 37920, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: October 15, 2024
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)