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

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-21

Study Completion Date

2025-07-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blinded

Study Groups

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MK-2225 Panel A

Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks.

Group Type EXPERIMENTAL

MK-2225

Intervention Type DRUG

Subcutaneous administration

MK-2225 Panel B

Participants receive MK-2225 Dose 2 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.

Group Type EXPERIMENTAL

MK-2225

Intervention Type DRUG

Subcutaneous administration

MK-2225 Panel C

Participants receive MK-2225 Dose 3 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.

Group Type EXPERIMENTAL

MK-2225

Intervention Type DRUG

Subcutaneous administration

MK-2225 Panel D

Participants receive MK-2225 Dose 4 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.

Group Type EXPERIMENTAL

MK-2225

Intervention Type DRUG

Subcutaneous administration

Placebo

Participants receive placebo SQ Q2W over the MK-2225-matched time period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous administration

Interventions

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MK-2225

Subcutaneous administration

Intervention Type DRUG

Placebo

Subcutaneous administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Is in good health before randomization
* Body Mass Index (BMI) ≤32 kg/m\^2, inclusive

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes