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NCT Number: NCT07743151

A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)

The purpose of this trial is to compare what happens to MK-1406 in the body of healthy participants when it is given as 2-injections and 3-injections. Researchers also want to learn about the safety of MK-1406 and if people tolerate it.

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Centers of America ( Hollywood ) ( Site 0008), Hollywood, 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 main inclusion criteria include but are not limited to the following:

  • Is in good health
  • Has body mass index (BMI) 18.0 to 32.0 kg/m^2

Exclusion criteria

The main 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 cancer (malignancy)

Treatment and study plan

MK-1406

Drug

Subcutaneous administration

Primary outcomes

  1. Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406

    Time frame: Predose and at designated timepoints up to 4 weeks postdose

    Blood samples will be collected at pre-specified timepoints to determine the AUC0-4w of MK-1406.

  2. Part 1 and Part 2: Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 43 days postdose

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  3. Part 1 and Part 2: Number of Participants Who Experience At Least One Solicited Injection-Site Reaction

    Time frame: Up to approximately 7 days postdose

    Solicited injection-site reactions include tenderness, pain, redness/erythema, and swelling. Participants will record injection site reactions using a paper diary. The number of participants with solicited injection-site reactions will be reported.

  4. Part 1 and Part 2: Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 43 days postdose

    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 due to an AE will be reported.

Secondary outcomes

  1. Part 1: Maximum Plasma Concentration (Cmax) of MK-1406

    Time frame: Predose and at designated timepoints up to 4 weeks postdose

    Blood samples will be collected at pre-specified timepoints to determine the Cmax of MK-1406.

  2. Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-1406

    Time frame: Predose and at designated timepoints up to 4 weeks postdose

    Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-1406.

  3. Part 1: Plasma Concentration of MK-1406 at 4 Weeks (C4w)

    Time frame: Predose and at designated timepoints up to 4 weeks postdose

    Blood samples will be collected at pre-specified timepoints to determine the C4w of MK-1406.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Open Label, Parallel Group Phase 1 Study to Compare Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MK-1406 as Three Injections Compared With Two Injections in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2026
Registry last updated
Sep 24, 2026

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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