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

Phase 1

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Placebo; Drug: Tulisokibart

• Registration Number: NCT06829225
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-13
• Primary Completion: 2024-11-11
• Study Completion: 2024-11-11
• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo SC Injection	Placebo	Participants will receive a single SC injection dose of placebo at on Day 1.
Placebo IV Infusion	Placebo	Participants will receive a single IV infusion dose of placebo on Day 1.
Tulisokibart Dose 1 Treatment Subcutaneous (SC) Injection	Tulisokibart	Participants will receive a single SC injection dose of tulisokibart at dose 1 on Day 1.
Tulisokibart Dose 2 IV Infusion	Tulisokibart	Participants will receive a single IV infusion dose of tulisokibart at dose 2 on Day 1.
Tulisokibart Dose 1 Intravenous (IV) Infusion	Tulisokibart	Participants will receive a single IV infusion dose of tulisokibart at dose 1 on Day 1.
Tulisokibart Dose 3 IV Infusion	Tulisokibart	Participants will receive a single IV infusion dose of tulisokibart at dose 3 on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	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.
Number of Participants Who Discontinued the Study Due to AEs	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.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Tulisokibart	Predose and at designated timepoints (up to 99 days postdose)	Blood samples will be collected to determine the AUC0-last of tulisokibart.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Tulisokibart	Predose and at designated timepoints (up to 99 days postdose)	Blood samples will be collected to determine the AUC0-inf of tulisokibart.
Maximum Concentration (Cmax) of Tulisokibart	Predose and at designated timepoints (up to 99 days postdose)	Blood samples will be collected to determine the Cmax of tulisokibart.
Time to Maximum Concentration (Tmax) of Tulisokibart	Predose and at designated timepoints (up to 99 days postdose)	Blood samples will be collected to determine the Tmax of tulisokibart.
Apparent Terminal Half-life (t1/2) of Tulisokibart	Predose and at designated timepoints (up to 99 days postdose)	Blood samples will be collected to determine the t1/2 of tulisokibart.
Apparent Clearance (CL/F) of Tulisokibart	Predose and at designated timepoints (up to 99 days postdose)	Blood samples will be collected to determine the CL/F of tulisokibart.
Apparent Volume of Distribution (Vz/F) of Tulisokibart	Predose and at designated timepoints (up to 99 days postdose)	Blood samples will be collected to determine the Vz/F of tulisokibart.

Secondary Outcome Measures

Name	Time	Method
Absolute Bioavailability Expressed as a Percentage (F%) of SC Tulisokibart	Predose and at designated timepoints (up to 99 days postdose)	Blood samples will be collected to determine the F% of tulisokibart.

Trial Locations

Locations (1)

Peking University Third Hospital (Site 0001); 🇨🇳 Beijing, Beijing, China