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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2225-003 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-2225 Panel A | Experimental | Participants receive MK-2225 Dose 1 subcutaneously (SQ) once every 2 weeks (Q2W) over the course of 8 weeks. |
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| MK-2225 Panel B | Experimental | 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. |
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| MK-2225 Panel C | Experimental | 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. |
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| MK-2225 Panel D | Experimental | 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. |
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| Placebo | Placebo Comparator | Participants receive placebo SQ Q2W over the MK-2225-matched time period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2225 | Drug | Subcutaneous administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 20 weeks |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of MK-2225 | Blood samples will be collected to determine the Cmax of MK-2225. | At designated timepoints (up to approximately 16 weeks) |
| Lowest Plasma Concentration (Ctrough) of MK-2225 |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami (Site 0002) | Miami | Florida | 33014-3616 | United States | ||
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO (Site 0004) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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Double blinded
| Placebo | Other | Subcutaneous administration |
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Blood samples will be collected to determine the Ctrough of MK-2225.
| At designated timepoints (up to approximately 16 weeks) |
| Time to Maximum Plasma Concentration (Tmax) of MK-2225 | Blood samples will be collected to determine the Tmax of MK-2225. | At designated timepoints (up to approximately 16 weeks) |
| Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225 | Blood samples will be collected to determine the AUC0-τ of MK-2225. | At designated timepoints (up to 16 approximately weeks) |
| Apparent Terminal Half-life (t1/2) of MK-2225 | Blood samples will be collected to determine the t1/2 of MK-2225. | At designated timepoints (up to approximately 16 weeks) |
| Mean Accumulation Ratio of MK-2225 | Blood samples will be collected at designated timepoints to determine the mean accumulation ratio of MK-2225. | At designated timepoints (up to approximately 16 weeks) |
| Springfield |
| Missouri |
| 65802 |
| United States |