HealthyPhase 1NCT07405177
A Study of MK-7240 in Healthy Participants (MK-7240-009)
A Phase 1 study testing Tulisokibart Form 1 and Tulisokibart Form 2 in people with Healthy, run by Merck Sharp & Dohme LLC at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tulisokibart Form 1 and Tulisokibart Form 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesAustralia
- Study dates
- 5 Mar 2026to 12 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Nucleus Network ( Site 0002)
Brisbane, Queensland, 4006
Nucleus Network ( Site 0001)
Melbourne, Victoria, 3004
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Tulisokibart Form 1, Tulisokibart Form 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tulisokibart Form 1Biological
Also called MK-7240
Solution for injection.
Tulisokibart Form 2Biological
Also called MK-7240
Solution for injection.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Tulisokibart Form 1 | Experimental | Participants will receive tulisokibart form 1. Receives: Biological: Tulisokibart Form 1 |
| Arm 2: Tulisokibart Form 2 | Experimental | Participants will receive tulisokibart form 2. Receives: Biological: Tulisokibart Form 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At designated timepoints up to 14 weeks
Maximum Plasma Concentration (Cmax) of Tulisokibart
Blood samples will be collected to determine the Cmax of tulisokibart.
Measured: At designated timepoints up to 14 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At designated timepoints up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start5 Mar 2026
- Primary completion19 Sep 2026
- Study completion12 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405177
- Sponsor's protocol ID
- 7240-009
- Other IDs
- MK-7240-009
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07405177
- Acronym / sponsor ID
- 7240-009
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 19 Sep 2026 (actual)
- Study completion
- 12 Oct 2026 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Tulisokibart Form 1 | Experimental | Biological: Tulisokibart Form 1Participants will receive tulisokibart form 1. |
| Arm 2: Tulisokibart Form 2 | Experimental | Biological: Tulisokibart Form 2Participants will receive tulisokibart form 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has a body-mass index (BMI) between 18 and 32 kg/m^2
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tulisokibart Form 1Also: MK-7240Solution for injection. | Biological | Arm 1: Tulisokibart Form 1 |
| Tulisokibart Form 2Also: MK-7240Solution for injection. | Biological | Arm 2: Tulisokibart Form 2 |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart
Time frame: 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
Time frame: 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
Time frame: At designated timepoints up to 14 weeks
Blood samples will be collected to determine the Cmax of tulisokibart.
9 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: At designated timepoints up to 14 weeks
Number of Participants Who Discontinue Study Due to an AE
Time frame: At designated timepoints up to 14 weeks
Time to Maximum Plasma Concentration (Tmax) of Tulisokibart
Time frame: At designated timepoints up to 14 weeks
Apparent Clearance (CL/F) of Tulisokibart
Time frame: At designated timepoints up to 14 weeks
Apparent Volume of Distribution (V/F) of Tulisokibart
Time frame: At designated timepoints up to 14 weeks
Apparent Terminal Half-life (t1/2) of Tulisokibart
Time frame: At designated timepoints up to 14 weeks
Apparent Terminal Elimination Rate constant (Kel) of Tulisokibart
Time frame: At designated timepoints up to 14 weeks
Ratio of AUC0-Last/AUC0-Inf of Tulisokibart
Time frame: At designated timepoints up to 14 weeks
Area Under the Concentration-Time Curve from Time 0 to Day 14 (pAUC0-14) of Tulisokibart
Time frame: At designated timepoints up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tulisokibart Form 1 and Tulisokibart Form 2 in people with Healthy, run by Merck Sharp & Dohme LLC at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart (time frame: At designated timepoints up to 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.