MK-7240 in healthy adults
A Randomized, Open-label, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Tulisokibart Delivered by 2 Different Autoinjectors in Healthy Participants
We will test how the body processes MK-7240 and whether healthy adults tolerate it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 2 sites (Brisbane, Queensland and 1 other locations) |
| Trial ID | NCT07405177 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pharmacokinetic trial gives healthy adult participants one or more formulations of MK-7240 (Tulisokibart Form 1 or Form 2) and collects blood samples over time to measure drug levels. Safety and tolerability are monitored through clinical exams, laboratory tests, and recording of adverse events. Key eligibility includes adults with a BMI between 18 and 32 kg/m^2 and exclusion of those with multiple or disseminated herpes zoster or active/untreated latent tuberculosis. Study visits are conducted at Nucleus Network sites in Melbourne and Brisbane, Australia.
Who should consider this trial
Good fit: Ideal candidates are healthy adults with a BMI of 18–32 kg/m^2 who can attend visits at the Melbourne or Brisbane sites and who have no history of multiple/disseminated herpes zoster or untreated TB.
Not a fit: People with active or untreated latent tuberculosis, a history of more than one or disseminated herpes zoster infection, or those with significant medical conditions are unlikely to be eligible or to benefit directly from this study.
Why it matters
Potential benefit: If successful, the results will clarify safe dosing and timing to guide later trials that could enable future treatments.
How similar studies have performed: Pharmacokinetic and safety studies in healthy volunteers are a standard early step in drug development and have routinely informed dosing for later successful trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brisbane, Queensland and 1 other locations
- Nucleus Network ( Site 0002) — Brisbane, Queensland, Australia (Recruiting)
- Nucleus Network ( Site 0001) — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.