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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Venous Thrombosis

Treatments: Biological: MK-2060; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06582602

2060-016

MK-2060-016 (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 when MK-2060 is given in different forms.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 50 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) between ≥18 and ≤32 kg/m^2, inclusive

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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64 participants in 6 patient groups, including a placebo group

Panel A: MK-2060 IV (20 minutes)

Experimental group

Description:

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

Treatment:

Biological: MK-2060

Panel B: MK-2060 IV (10 minutes)

Experimental group

Description:

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

Treatment:

Biological: MK-2060

Panel C: MK-2060 IV (5 minutes)

Experimental group

Description:

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

Treatment:

Biological: MK-2060

Panel D: MK-2060 IV (2.5 minutes)

Experimental group

Description:

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

Treatment:

Biological: MK-2060

Panel E: MK-2060 IV (1 minute)

Experimental group

Description:

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

Treatment:

Biological: MK-2060

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo