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

Merck Sharp & Dohme LLC36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

MK-2060BIOLOGICAL

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

PlaceboBIOLOGICAL

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

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

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 164 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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