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Colitis, UlcerativePhase 1NCT06829225

Single Dose Study of Tulisokibart (MK-7240) in Healthy Chinese Participants (MK-7240-002)

A Phase 1 study testing Tulisokibart in people with Colitis, Ulcerative, run by Merck Sharp & Dohme LLC at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to learn about the safety of tulisokibart in healthy participants and what happens to tulisokibart over time when participants receive treatment intravenously versus subcutaneously. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Tulisokibart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteChina
Study dates
13 Jun 2024to 11 Nov 2024
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

  • Be in good health
  • Has a body mass index (BMI) ≥18 and ≤28 kg/m^2 and weight ≥40.0 kg
  • Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the dosing of study drug

Who cannot join

  • History of cancer (malignancy)
  • Has positive serum test for human immunodeficiency virus (HIV), hepatitis C or hepatitis B virus infection

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital (Site 0001)

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-7240 in Healthy Chinese Participants.

The goal of this study is to learn about the safety of tulisokibart in healthy participants and what happens to tulisokibart over time when participants receive treatment intravenously versus subcutaneously.

Being tested
Tulisokibart, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TulisokibartDrug

    Also called MK-7240

    SC Injection or IV Infusion

  • PlaceboDrug

    Tulisokibart-matched Placebo SC Injection or IV Infusion

Study groups in NCT06829225
Study groupRoleWhat they receive
Tulisokibart Dose 1 Treatment Subcutaneous (SC) InjectionExperimentalParticipants will receive a single SC injection dose of tulisokibart at dose 1 on Day 1.
Receives: Drug: Tulisokibart
Placebo SC InjectionPlacebo comparatorParticipants will receive a single SC injection dose of placebo at on Day 1.
Receives: Drug: Placebo
Tulisokibart Dose 1 Intravenous (IV) InfusionExperimentalParticipants will receive a single IV infusion dose of tulisokibart at dose 1 on Day 1.
Receives: Drug: Tulisokibart
Tulisokibart Dose 2 IV InfusionExperimentalParticipants will receive a single IV infusion dose of tulisokibart at dose 2 on Day 1.
Receives: Drug: Tulisokibart
Tulisokibart Dose 3 IV InfusionExperimentalParticipants will receive a single IV infusion dose of tulisokibart at dose 3 on Day 1.
Receives: Drug: Tulisokibart
Placebo IV InfusionPlacebo comparatorParticipants will receive a single IV infusion dose of placebo on Day 1.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 the study intervention, whether or not considered related to the study intervention.

    Measured: Up to 99 Days

  2. Number of Participants Who Discontinued the Study Due to AEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

    Measured: Up to 99 days

  3. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Tulisokibart

    Blood samples will be collected to determine the AUC0-last of tulisokibart.

    Measured: Predose and at designated timepoints (up to 99 days postdose)

  4. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Tulisokibart

    Blood samples will be collected to determine the AUC0-inf of tulisokibart.

    Measured: Predose and at designated timepoints (up to 99 days postdose)

  5. Maximum Concentration (Cmax) of Tulisokibart

    Blood samples will be collected to determine the Cmax of tulisokibart.

    Measured: Predose and at designated timepoints (up to 99 days postdose)

  6. Time to Maximum Concentration (Tmax) of Tulisokibart

    Blood samples will be collected to determine the Tmax of tulisokibart.

    Measured: Predose and at designated timepoints (up to 99 days postdose)

  7. Apparent Terminal Half-life (t1/2) of Tulisokibart

    Blood samples will be collected to determine the t1/2 of tulisokibart.

    Measured: Predose and at designated timepoints (up to 99 days postdose)

  8. Apparent Clearance (CL/F) of Tulisokibart

    Blood samples will be collected to determine the CL/F of tulisokibart.

    Measured: Predose and at designated timepoints (up to 99 days postdose)

  9. Apparent Volume of Distribution (Vz/F) of Tulisokibart

    Blood samples will be collected to determine the Vz/F of tulisokibart.

    Measured: Predose and at designated timepoints (up to 99 days postdose)

Secondary outcomes (1)

  1. Absolute Bioavailability Expressed as a Percentage (F%) of SC Tulisokibart

    Blood samples will be collected to determine the F% of tulisokibart.

    Measured: Predose and at designated timepoints (up to 99 days postdose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start13 Jun 2024
  3. Primary completion11 Nov 2024
  4. Study completion11 Nov 2024

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06829225
Sponsor's protocol ID
7240-002
Other IDs
MK-7240-002
Status last verified
Feb 2025
First submitted
11 Feb 2025
Last updated
17 Feb 2025
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tulisokibart in people with Colitis, Ulcerative, run by Merck Sharp & Dohme LLC at 1 site in China.

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 3 inclusion and 2 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?

Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to 99 Days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06829225.

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 17 Feb 2025.

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