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

NCT06829225 | Completed Phase 1 FDA Drug

• 2 other identifiers: 7240-002MK-7240-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colitis, Ulcerative

Outcome Measures

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

  Up to 99 Days

• 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.

  Up to 99 days

• 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.

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

• 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.

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

• Maximum Concentration (Cmax) of Tulisokibart

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

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

• Time to Maximum Concentration (Tmax) of Tulisokibart

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

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

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

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

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

• Apparent Clearance (CL/F) of Tulisokibart

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

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

• Apparent Volume of Distribution (Vz/F) of Tulisokibart

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

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

Secondary Outcomes (1)

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

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

Study Arms (6)

Tulisokibart Dose 1 Treatment Subcutaneous (SC) Injection

EXPERIMENTAL

Participants will receive a single SC injection dose of tulisokibart at dose 1 on Day 1.

Drug: Tulisokibart

Placebo SC Injection

PLACEBO COMPARATOR

Participants will receive a single SC injection dose of placebo at on Day 1.

Drug: Placebo

Tulisokibart Dose 1 Intravenous (IV) Infusion

EXPERIMENTAL

Participants will receive a single IV infusion dose of tulisokibart at dose 1 on Day 1.

Drug: Tulisokibart

Tulisokibart Dose 2 IV Infusion

EXPERIMENTAL

Participants will receive a single IV infusion dose of tulisokibart at dose 2 on Day 1.

Drug: Tulisokibart

Tulisokibart Dose 3 IV Infusion

EXPERIMENTAL

Participants will receive a single IV infusion dose of tulisokibart at dose 3 on Day 1.

Drug: Tulisokibart

Placebo IV Infusion

PLACEBO COMPARATOR

Participants will receive a single IV infusion dose of placebo on Day 1.

Drug: Placebo

Interventions

Tulisokibart DRUG

SC Injection or IV Infusion

Also known as: MK-7240

Tulisokibart Dose 1 Intravenous (IV) Infusion; Tulisokibart Dose 1 Treatment Subcutaneous (SC) Injection; Tulisokibart Dose 2 IV Infusion; Tulisokibart Dose 3 IV Infusion

Placebo DRUG

Tulisokibart-matched Placebo SC Injection or IV Infusion

Placebo IV Infusion; Placebo SC Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Peking University Third Hospital (Site 0001)

Beijing, Beijing Municipality, 100191, China

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: June 13, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)