A Study of MK-7240 in Healthy Participants (MK-7240-009)
- 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.
- Short title
- A Study of MK-7240 in Healthy Participants (MK-7240-009)
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-09-03
- First posted
- 2026-02-12
- Registry last updated
- 2026-06-10
- Primary completion date
- 2026-09-03
- Start date
- 2026-03-05
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07405177
- ClinicalTrials.gov ID
- NCT07405177
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- No masking
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart
Timeframe: 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
Timeframe: 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
Timeframe: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the Cmax of tulisokibart.
Number of Participants Who Experience an Adverse Event (AE)
Timeframe: 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
Timeframe: 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
Timeframe: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the Tmax of tulisokibart.
Apparent Clearance (CL/F) of Tulisokibart
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: At designated timepoints up to 14 days
Blood samples will be collected to determine pAUC0-14 of tulisokibart.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- 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
- Nucleus Network ( Site 0002)Brisbane, Australia
- Nucleus Network ( Site 0001)Melbourne, Australia
- Related resource (www.merckclinicaltrials.com)
Other registry identifiers
- MK-7240-009