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Completed

NCT Number: NCT06829225

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

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.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital (Site 0001)

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

include, but are not limited to:

  • 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

Exclusion criteria

Exclusion criteria

include, but are not limited to:

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

Treatment and study plan

Tulisokibart

Drug

SC Injection or IV Infusion

Other names: MK-7240

Placebo

Drug

Tulisokibart-matched Placebo SC Injection or IV Infusion

Primary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to 99 Days

    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.

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

    Time frame: Up to 99 days

    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.

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

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

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

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

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

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

  5. Maximum Concentration (Cmax) of Tulisokibart

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

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

  6. Time to Maximum Concentration (Tmax) of Tulisokibart

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

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

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

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

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

  8. Apparent Clearance (CL/F) of Tulisokibart

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

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

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

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

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

Secondary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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