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Clinical Trial NCT07405177 for Healthy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Merck Sharp & Dohme LLCA Study of MK-7240 in Healthy Participants (MK-7240-009) Phase 1 330
Clinical Trial NCT07405177 is designed to study Basic Science for Healthy. It is a Phase 1 interventional study that is recruiting, having started on 5 March 2026, with plans to enroll 330 participants. Led by Merck Sharp & Dohme LLC, it is expected to complete by 3 September 2026. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
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.
Official 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
Conditions
HealthyOther Study IDs
- 7240-009
- MK-7240-009 (Other Identifier) (MSD)
NCT ID Number
Start Date (Actual)
2026-03-05
Last Update Posted
2026-03-20
Completion Date (Estimated)
2026-09-03
Enrollment (Estimated)
330
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm 1: Tulisokibart Form 1 Participants will receive tulisokibart form 1. | Tulisokibart Form 1 Solution for injection. |
ExperimentalArm 2: Tulisokibart Form 2 Participants will receive tulisokibart form 2. | Tulisokibart Form 2 Solution for injection. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart | Blood samples will be collected to determine the AUC0-inf of tulisokibart. | At designated timepoints up to 14 weeks |
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tulisokibart | Blood samples will be collected to determine the AUC0-last of tulisokibart. | At designated timepoints up to 14 weeks |
Maximum Plasma Concentration (Cmax) of Tulisokibart | Blood samples will be collected to determine the Cmax of tulisokibart. | At designated timepoints up to 14 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | At designated timepoints up to 14 weeks |
Number of Participants Who Discontinue Study 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. | At designated timepoints up to 14 weeks |
Time to Maximum Plasma Concentration (Tmax) of Tulisokibart | Blood samples will be collected to determine the Tmax of tulisokibart. | At designated timepoints up to 14 weeks |
Apparent Clearance (CL/F) of Tulisokibart | Blood samples will be collected to determine the CL/F of tulisokibart. | At designated timepoints up to 14 weeks |
Apparent Volume of Distribution (V/F) of Tulisokibart | Blood samples will be collected to determine the V/F of tulisokibart. | At designated timepoints up to 14 weeks |
Apparent Terminal Half-life (t1/2) of Tulisokibart | Blood samples will be collected to determine the t1/2 of tulisokibart. | At designated timepoints up to 14 weeks |
Apparent Terminal Elimination Rate constant (Kel) of Tulisokibart | Blood samples will be collected to determine the Kel of tulisokibart. | At designated timepoints up to 14 weeks |
Ratio of AUC0-Last/AUC0-Inf of Tulisokibart | Blood samples will be collected to determine the ratio of AUC0-last/AUC0-inf of tulisokibart. | At designated timepoints up to 14 weeks |
Area Under the Concentration-Time Curve from Time 0 to Day 14 (pAUC0-14) of Tulisokibart | Blood samples will be collected to determine pAUC0-14 of tulisokibart. | At designated timepoints up to 14 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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
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
Merck Sharp & Dohme LLC707 active studies to exploreStudy Central Contact
Contact: Toll Free Number, 1-888-577-8839, [email protected]
2 Study Locations in 1 Countries
Queensland
Nucleus Network ( Site 0002), Brisbane, Queensland, 4006, Australia
Study Coordinator, Contact, +61737072720
Recruiting
Victoria
Nucleus Network ( Site 0001), Melbourne, Victoria, 3004, Australia
Study Coordinator, Contact, +6138593 9801
Recruiting