A Study of MK-2225 in Healthy Participants (MK-2225-003)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 1

Conditions: Systemic Sclerosis

Treatments: Drug: MK-2225; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06643390

2225-003

MK-2225-003 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to learn about the safety of MK-2225, including how well people tolerate it. Researchers also want to learn what happens to different doses of MK-2225 in a person's body over time.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

• Is in good health before randomization
• Body Mass Index (BMI) ≤32 kg/m^2, inclusive

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

• 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
• History of hypersensitivity to the MK-2225 drug substance, its inactive ingredients or the placebo (normal saline)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 5 patient groups, including a placebo group

MK-2225 Panel A

Experimental group

Description:

Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks.

Treatment:

Drug: MK-2225

MK-2225 Panel B

Experimental group

Description:

Participants receive MK-2225 Dose 2 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.

Treatment:

Drug: MK-2225

MK-2225 Panel C

Experimental group

Description:

Participants receive MK-2225 Dose 3 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.

Treatment:

Drug: MK-2225

MK-2225 Panel D

Experimental group

Description:

Participants receive MK-2225 Dose 4 SQ Q2W over the course of 8 weeks based on the safety and tolerability of the previous starting dose.

Treatment:

Drug: MK-2225

Placebo

Placebo Comparator group

Description:

Participants receive placebo SQ Q2W over the MK-2225-matched time period.

Treatment:

Other: Placebo