A Study of MK-2225 in Healthy Participants (MK-2225-003)

Merck Sharp & Dohme LLC32 enrolled

Overview

The purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to different doses of MK-2225 in a person's body over time.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Systemic Sclerosis

Interventions

MK-2225DRUG

Subcutaneous administration

PlaceboOTHER

Subcutaneous administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 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 * Body Mass Index (BMI) ≤32 kg/m\^2, inclusive Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * 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 * History of hypersensitivity to the MK-2225 drug substance, its inactive ingredients or the placebo (normal saline)

Locations (2)

Clinical Pharmacology of Miami (Site 0002)

Miami, Florida, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO (Site 0004)

Springfield, Missouri, United States

Outcomes

Primary Outcomes

Number of Participants Who Experience an Adverse Event (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. The number of participants who experience an AE will be reported.

Time frame: Up to approximately 20 weeks

Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 8 weeks

Secondary Outcomes

Maximum Plasma Concentration (Cmax) of MK-2225

Blood samples will be collected to determine the Cmax of MK-2225.

Time frame: At designated timepoints (up to approximately 16 weeks)

Lowest Plasma Concentration (Ctrough) of MK-2225

Blood samples will be collected to determine the Ctrough of MK-2225.

Time frame: At designated timepoints (up to approximately 16 weeks)

Time to Maximum Plasma Concentration (Tmax) of MK-2225

Blood samples will be collected to determine the Tmax of MK-2225.

Time frame: At designated timepoints (up to approximately 16 weeks)

Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225

Blood samples will be collected to determine the AUC0-τ of MK-2225.

Time frame: At designated timepoints (up to 16 approximately weeks)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.