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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: MK-2060; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06843993

2060-009

MK-2060-009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

Panel A: MK-2060 Dose 1

Experimental group

Description:

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

Treatment:

Biological: MK-2060

Panel B: MK-2060 Dose 2

Experimental group

Description:

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.

Treatment:

Biological: MK-2060

Panel C: MK-2060 Dose 3

Experimental group

Description:

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.

Treatment:

Biological: MK-2060

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo