Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Tulisokibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT06575595

MK-7240-010 (Other Identifier)

7240-010

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is in good health
• Has a body mass index (BMI) between 18 and 32 kg/m2, inclusive
• Has a weight between 50 and 100 kg, inclusive

Exclusion criteria

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
• Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years or has had diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) in which the possibility of malignancy cannot be reasonably excluded following additional clinical assessments
• 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)
• Has a history of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection
• Has a history of or current active tuberculosis (TB) infection; history of latent TB that was not fully treated or a positive QuantiFERON-TB test at screening
• Is a smoker and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening
• Consumes greater than 3 servings of alcoholic beverages per day
• Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Treatment A

Experimental group

Description:

Single dose delivered subcutaneously (SC) with an autoinjector

Treatment:

Biological: Tulisokibart

Treatment B

Experimental group

Description:

Single dose of concentration A delivered SC with syringe and vial

Treatment:

Biological: Tulisokibart

Treatment C

Experimental group

Description:

Single dose of concentration B delivered SC with syringe and vial

Treatment:

Biological: Tulisokibart