Status:
COMPLETED
Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06575595
Start Date
September 24 2024
End Date
January 31 2025
Last Update
February 18 2025
Active Locations (1)
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1
QPS Missouri ( Site 0003)
Springfield, Missouri, United States, 65802