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MK-2225 Safety Study
Springfield, MO
Phase 1
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
History of clinically significant respiratory abnormalities
History of clinically significant gastrointestinal abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 20 weeks
Summary
This trial aims to understand how safe and well-tolerated MK-2225 is in people, as well as how the body processes different doses of MK-2225 over time.
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Who is the study for?
This clinical trial is for healthy individuals who are interested in contributing to research on a new medication, MK-2225. Specific eligibility criteria were not provided, so it's important to contact the study organizers for detailed requirements.Check my eligibility
What is being tested?
The study is testing the safety and tolerability of different doses of a new drug called MK-2225 compared to a placebo (a substance with no active drug). It also examines how the body processes the drug over time.See study design
What are the potential side effects?
Since this is an early-stage trial for MK-2225, potential side effects are being investigated. Common side effects may include reactions at the injection site, nausea, headache or fatigue but will be confirmed through this study.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had serious lung or breathing problems.
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I have had serious stomach or intestine problems.
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I have a history of serious heart problems.
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I have a history of significant urinary system issues.
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I have a history of major neurological issues like stroke or chronic seizures.
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I have a history of significant liver problems.
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I have had significant kidney problems in the past.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience an Adverse Event (AE)
Secondary study objectives
Apparent Terminal Half-life (t1/2) of MK-2225
Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225
LowestPlasma Concentration (Ctrough) of MK-2225
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-2225Experimental Treatment1 Intervention
Participants receive MK-2225 titrated from Dose 1, Dose 2, or Dose 3, subcutaneously (SC) once every 2 weeks (Q2W) over the course of 8 weeks based on the safety and tolerability of the previous starting dose.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive placebo SC Q2W over the course of 8 weeks.
Find a Location
Closest Location:Bio-Kinetic Clinical Applications, LLC dba QPS-MO (Site 0004)· Springfield, MO
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,086 Previous Clinical Trials
5,223,883 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,964 Previous Clinical Trials
8,098,725 Total Patients Enrolled