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The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them. The study will also measure what happens to sotatercept in a person's body over time (pharmacokinetic or PK study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotatercept Dose Level 1 | Experimental | Participants received a single dose of sotatercept at dose level 1. |
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| Sotatercept Dose Level 2 | Experimental | Participants received a single dose of sotatercept at dose level 2. |
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| Placebo | Placebo Comparator | Participants received a single dose of placebo to sotatercept. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | Single subcutaneous injection |
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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 120 days |
| Number of Participants Who Discontinue Study 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 due to an AE will be reported. | Up to approximately 120 days |
| Maximum Serum Concentration (Cmax) of Sotatercept | Blood samples will be collected to determine the Cmax of sotatercept. | At designated timepoints (up to 120 days) |
| Time to Maximum Serum Concentration (Tmax) of Sotatercept | Blood samples will be collected to determine the Tmax of sotatercept. | Predose and at designated timepoints up to 120 days postdose |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962 | Blood samples will be collected to determine the AUC0-last of MK-7962. | At designated timepoints (up to 120 days) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962 | Blood samples will be collected to determine the AUC0-inf of MK-7962. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main 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 |
|---|---|---|---|---|---|---|
| Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001) | Shanghai | Shanghai Municipality | 200032 | China |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C542017 | ACE-011 |
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The first 12 participants were randomized 1:3 between placebo or 0.3 mg/kg of sotatercept. After those 12 participants were complete, the next 12 were randomized 1:3 between placebo or 0.7 mg/kg of sotatercept.
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| Placebo | Other | Single subcutaneous injection |
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| At designated timepoints (up to 120 days) |
| Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962 | Blood samples will be collected to determine the AUC0-28 days of MK-7962. | At designated timepoints (up to 28 days postdose) |
| Apparent Terminal Half-life (t1/2) of MK-7962 | Blood samples will be collected to determine the t1/2 of MK-7962. | At designated timepoints (up to 120 days) |
| Apparent Clearance (CL/F) of MK-7962 | Blood samples will be collected to determine the CL/F of MK-7962. | At designated timepoints (up to 120 days) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962 | Blood samples will be collected to determine the Vz/F of MK-7962. | At designated timepoints (up to 120 days) |