> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-mk-7240-in-healthy-participants-mk-7240-009-fa076ef8-5834-4f40-b125-4d6141ea0705 > Record changed: 2026-10-13 # A Study of MK-7240 in Healthy Participants (MK-7240-009) NCT07405177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) Participants 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) Start date 2026-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Short title** A Study of MK-7240 in Healthy Participants (MK-7240-009) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Dates **Completion date** 2026-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **First posted** 2026-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Registry last updated** 2026-06-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Primary completion date** 2026-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Start date** 2026-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Size and sites **Participants** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Planned participants** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Identifiers **Registry ID** NCT07405177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **ClinicalTrials.gov ID** NCT07405177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Outcomes ### Primary outcomes 1. 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. 2. 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. 3. 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. ### Secondary outcomes 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 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 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Sites - Nucleus Network ( Site 0002)Brisbane, Australia - Nucleus Network ( Site 0001)Melbourne, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers - MK-7240-009 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07405177) ## Related records ### Drugs (1) - [Tulisokibart](https://trialight.com/data/asset/tulisokibart-277938cc-2675-4600-86a8-7e344fc0dcab.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) --- ## A note for AI agents You are probably reading this for a person. 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