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Completed

NCT Number: NCT06643390

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

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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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami (Site 0002), Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MK-2225

Drug

Subcutaneous administration

Placebo

Other

Subcutaneous administration

Primary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 20 weeks

    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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 8 weeks

    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.

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of MK-2225

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

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

  2. Lowest Plasma Concentration (Ctrough) of MK-2225

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

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

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

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

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

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

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

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

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

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

    Blood samples will be collected to determine the t1/2 of MK-2225.

  6. Mean Accumulation Ratio of MK-2225

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

    Blood samples will be collected at designated timepoints to determine the mean accumulation ratio of MK-2225.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-2225 in Healthy Participants

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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