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Active, Not Recruiting

NCT Number: NCT07405177

A Study of MK-7240 in Healthy Participants (MK-7240-009)

The goal of this study is to learn what happens to MK-7240 in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of MK-7240 and if people tolerate it.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network ( Site 0002), Brisbane, Queensland, Australia

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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:

  • Has a body-mass index (BMI) between 18 and 32 kg/m^2

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has a history of more than 1 episode of herpes zoster infection or history of disseminated herpes zoster infection
  • Has a history of or current active tuberculosis (TB) infection or history of latent TB that was not fully treated

Treatment and study plan

Tulisokibart Form 1

Biological

Solution for injection.

Other names: MK-7240

Tulisokibart Form 2

Biological

Solution for injection.

Other names: MK-7240

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the AUC0-inf of tulisokibart.

  2. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the AUC0-last of tulisokibart.

  3. Maximum Plasma Concentration (Cmax) of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the Cmax of tulisokibart.

Secondary outcomes

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

    Time frame: At designated timepoints up to 14 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.

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

    Time frame: At designated timepoints up to 14 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.

  3. Time to Maximum Plasma Concentration (Tmax) of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the Tmax of tulisokibart.

  4. Apparent Clearance (CL/F) of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the CL/F of tulisokibart.

  5. Apparent Volume of Distribution (V/F) of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the V/F of tulisokibart.

  6. Apparent Terminal Half-life (t1/2) of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the t1/2 of tulisokibart.

  7. Apparent Terminal Elimination Rate constant (Kel) of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the Kel of tulisokibart.

  8. Ratio of AUC0-Last/AUC0-Inf of Tulisokibart

    Time frame: At designated timepoints up to 14 weeks

    Blood samples will be collected to determine the ratio of AUC0-last/AUC0-inf of tulisokibart.

  9. Area Under the Concentration-Time Curve from Time 0 to Day 14 (pAUC0-14) of Tulisokibart

    Time frame: At designated timepoints up to 14 days

    Blood samples will be collected to determine pAUC0-14 of tulisokibart.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Open-label, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Tulisokibart Delivered by 2 Different Autoinjectors in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Jun 10, 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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