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

NCT ID: NCT06829225

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-13

Study Completion Date

2024-11-11

Brief Summary

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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

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Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tulisokibart Dose 1 Treatment Subcutaneous (SC) Injection

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

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

SC Injection or IV Infusion

Placebo SC Injection

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tulisokibart-matched Placebo SC Injection or IV Infusion

Tulisokibart Dose 1 Intravenous (IV) Infusion

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

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

SC Injection or IV Infusion

Tulisokibart Dose 2 IV Infusion

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

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

SC Injection or IV Infusion

Tulisokibart Dose 3 IV Infusion

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

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

SC Injection or IV Infusion

Placebo IV Infusion

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tulisokibart-matched Placebo SC Injection or IV Infusion

Interventions

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Tulisokibart

SC Injection or IV Infusion

Intervention Type DRUG

Placebo

Tulisokibart-matched Placebo SC Injection or IV Infusion

Intervention Type DRUG

Other Intervention Names

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MK-7240

Eligibility Criteria

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Inclusion Criteria

* 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

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Peking University Third Hospital (Site 0001)

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-7240-002

Identifier Type: OTHER

Identifier Source: secondary_id

7240-002

Identifier Type: -

Identifier Source: org_study_id

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