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Completed

NCT Number: NCT06843993

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

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.

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Key information

Conditions

Healthy

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MK-2060

Biological

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

Placebo

Biological

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

Primary outcomes

  1. Number of participants who experience one or more adverse events (AEs)

    Time frame: Up to 164 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.

  2. Number of participants who discontinue study due to an AE

    Time frame: Up to 164 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.

  3. Number of participants who experience one or more AEs related to bleeding

    Time frame: Up to 164 days

    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.

Secondary outcomes

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

    Time frame: Predose Day 1 and end of infusion

    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.

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

    Time frame: At designated timepoints (up to 168 hours)

    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.

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

    Time frame: At designated timepoints (up to 150 days)

    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.

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

    Time frame: At designated timepoints (up to 168 hours)

    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.

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

    Time frame: At designated timepoints (up to 150 days)

    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.

  6. Terminal half-life of MK-2060

    Time frame: At designated timepoints (up to 150 days)

    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.

  7. Clearance (CL) of MK-2060

    Time frame: At designated timepoints (up to 150 days)

    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.

  8. Volume of distribution (Vz) of MK-2060

    Time frame: At designated timepoints (up to 150 days)

    Vz is defined as the distributed volume of MK-2060 in plasma. Blood samples were collected at pre-specified time points to assess Vz.

  9. Change from baseline in activated partial thromboplastin time (aPTT)

    Time frame: Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days)

    Blood samples were collected at pre-specified time points to assess change from baseline in aPTT.

  10. Anti-drug antibodies (ADA) positive incidence

    Time frame: At designated timepoints (up to 150 days)

    Blood samples were collected at pre-specified time points to assess the incidence of anti-MK-2060 antibodies.

  11. Factor XI (FXI) activity level

    Time frame: At designated timepoints (up to 150 days)

    Blood samples were collected at pre-specified time points to assess FXI activity level.

  12. Prothrombin time (PT)

    Time frame: At designated timepoints (up to 150 days)

    Blood samples were collected at pre-specified time points to assess PT.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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