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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-10-27

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel A: MK-2060 Dose 1

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

Group Type EXPERIMENTAL

MK-2060

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

MK-2060

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

MK-2060

Intervention Type BIOLOGICAL

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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MK-2060

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes