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

NCT06643390 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2225-003MK-2225-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 20 weeks

• Number of Participants Who Discontinue Study Treatment Due to an 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 discontinue study/study treatment due to an AE will be reported.

  Up to approximately 8 weeks

Secondary Outcomes (6)

• Maximum Plasma Concentration (Cmax) of MK-2225

  At designated timepoints (up to approximately 16 weeks)

• Lowest Plasma Concentration (Ctrough) of MK-2225

  At designated timepoints (up to approximately 16 weeks)

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

  At designated timepoints (up to approximately 16 weeks)

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

  At designated timepoints (up to 16 approximately weeks)

• Apparent Terminal Half-life (t1/2) of MK-2225

  At designated timepoints (up to approximately 16 weeks)

Study Arms (5)

MK-2225 Panel A

EXPERIMENTAL

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

Drug: MK-2225

MK-2225 Panel B

EXPERIMENTAL

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.

Drug: MK-2225

MK-2225 Panel C

EXPERIMENTAL

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.

Drug: MK-2225

MK-2225 Panel D

EXPERIMENTAL

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.

Drug: MK-2225

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

MK-2225 DRUG

Subcutaneous administration

MK-2225 Panel A; MK-2225 Panel B; MK-2225 Panel C; MK-2225 Panel D

Placebo OTHER

Subcutaneous administration

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

Clinical Pharmacology of Miami (Site 0002)

Miami, Florida, 33014-3616, United States

Location

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

Springfield, Missouri, 65802, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: November 21, 2023
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)