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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Colitis, Ulcerative

Treatments: Drug: Placebo; Drug: Tulisokibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT06829225

MK-7240-002 (Other Identifier)

7240-002

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 6 patient groups, including a placebo group

Tulisokibart Dose 1 Treatment Subcutaneous (SC) Injection

Experimental group

Description:

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

Treatment:

Drug: Tulisokibart

Placebo SC Injection

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Tulisokibart Dose 1 Intravenous (IV) Infusion

Experimental group

Description:

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

Treatment:

Drug: Tulisokibart

Tulisokibart Dose 2 IV Infusion

Experimental group

Description:

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

Treatment:

Drug: Tulisokibart

Tulisokibart Dose 3 IV Infusion

Experimental group

Description:

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

Treatment:

Drug: Tulisokibart

Placebo IV Infusion

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo