Tulisokibart for Ulcerative Colitis

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, HIV, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objectives of the study are to characterize the pharmacokinetics (PK) of a single subcutaneous (SC) dose of tulisokibart (MK-7240) administered via autoinjector (AI) (Treatment A) and to characterize the PK of different concentrations of tulisokibart following SC administration of a single dose via vial/syringe (Treatments B and C). There is no formal hypothesis.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for individuals weighing between 50 and 100 kg, in good health, with a BMI of 18 to 32. It's designed for those with ulcerative colitis to test the drug Tulisokibart administered via an autoinjector or syringe.

Inclusion Criteria

I am in good health overall.

Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive

My weight is between 50 and 100 kg.

Exclusion Criteria

Consumes greater than 3 servings of alcoholic beverages per day

Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food

Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV); OR positive hepatitis B core antibody (HBcAb) with negative hepatitis B core antibody (HBsAb

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of tulisokibart via autoinjector or syringe

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics and safety through blood collection at specified time points

14 weeks

Multiple visits (in-person) on Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 29, 57, 71, and 99

Treatment Details

Interventions

• Tulisokibart

Trial Overview The study aims to understand how the body processes a single dose of Tulisokibart when given subcutaneously (under the skin) using either an autoinjector or vial/syringe at different concentrations.

Participant Groups

Group I: Treatment C Experimental Treatment 1 Intervention

Single dose of concentration B delivered SC with syringe and vial

Group II: Treatment B Experimental Treatment 1 Intervention

Single dose of concentration A delivered SC with syringe and vial

Group III: Treatment A Experimental Treatment 1 Intervention

Single dose delivered subcutaneously (SC) with an autoinjector

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University