A Study of MK-2225 in Healthy Participants (MK-2225-003)
- Registration Number
- NCT06643390
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 32
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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MK-2225 Panel A MK-2225 Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks. MK-2225 Panel B MK-2225 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. MK-2225 Panel C MK-2225 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. MK-2225 Panel D MK-2225 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. Placebo Placebo Participants receive placebo SQ Q2W over the MK-2225-matched time period.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 20 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE Up to approximately 8 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study/study treatment due to an AE will be reported.
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of MK-2225 At designated timepoints (up to approximately 16 weeks) Blood samples will be collected to determine the Cmax of MK-2225.
Lowest Plasma Concentration (Ctrough) of MK-2225 At designated timepoints (up to approximately 16 weeks) Blood samples will be collected to determine the Ctrough of MK-2225.
Time to Maximum Plasma Concentration (Tmax) of MK-2225 At designated timepoints (up to approximately 16 weeks) Blood samples will be collected to determine the Tmax of MK-2225.
Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225 At designated timepoints (up to 16 approximately weeks) Blood samples will be collected to determine the AUC0-τ of MK-2225.
Apparent Terminal Half-life (t1/2) of MK-2225 At designated timepoints (up to approximately 16 weeks) Blood samples will be collected to determine the t1/2 of MK-2225.
Mean Accumulation Ratio of MK-2225 At designated timepoints (up to approximately 16 weeks) Blood samples will be collected at designated timepoints to determine the mean accumulation ratio of MK-2225.
Trial Locations
- Locations (2)
Clinical Pharmacology of Miami (Site 0002)
🇺🇸Miami, Florida, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO (Site 0004)
🇺🇸Springfield, Missouri, United States