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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07405177

Enrollment

330

Registered

2026-02-12

Start date

2026-03-05

Completion date

2026-09-03

Last updated

2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

BIOLOGICALTulisokibart Form 1

Solution for injection.

BIOLOGICALTulisokibart Form 2

Solution for injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the AUC0-inf of tulisokibart.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the AUC0-last of tulisokibart.
Maximum Plasma Concentration (Cmax) of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the Cmax of tulisokibart.

Secondary

Measure	Time frame	Description
Number of Participants Who Experience an Adverse Event (AE)	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.
Number of Participants Who Discontinue Study Due to an AE	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.
Time to Maximum Plasma Concentration (Tmax) of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the Tmax of tulisokibart.
Apparent Clearance (CL/F) of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the CL/F of tulisokibart.
Apparent Volume of Distribution (V/F) of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the V/F of tulisokibart.
Apparent Terminal Half-life (t1/2) of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the t1/2 of tulisokibart.
Apparent Terminal Elimination Rate constant (Kel) of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the Kel of tulisokibart.
Ratio of AUC0-Last/AUC0-Inf of Tulisokibart	At designated timepoints up to 14 weeks	Blood samples will be collected to determine the ratio of AUC0-last/AUC0-inf of tulisokibart.
Area Under the Concentration-Time Curve from Time 0 to Day 14 (pAUC0-14) of Tulisokibart	At designated timepoints up to 14 days	Blood samples will be collected to determine pAUC0-14 of tulisokibart.

Countries

Australia

Contacts

STUDY_DIRECTORMedical Director

Merck Sharp & Dohme LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026