Healthy
Conditions
Brief summary
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).
Interventions
BIOLOGICALSotatercept
Single subcutaneous injection
OTHERPlacebo
Single subcutaneous injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Is in good health * Has a BMI≥18.0 kg/m\^2 and ≤28.0 kg/m\^2
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Serum Concentration (Tmax) of Sotatercept | Predose and at designated timepoints up to 120 days postdose | Blood samples will be collected to determine the Tmax of sotatercept. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 120 days | 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 Due to an AE | Up to approximately 120 days | 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. |
| Maximum Serum Concentration (Cmax) of Sotatercept | At designated timepoints (up to 120 days) | Blood samples will be collected to determine the Cmax of sotatercept. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962 | At designated timepoints (up to 120 days) | Blood samples will be collected to determine the AUC0-last of MK-7962. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962 | At designated timepoints (up to 120 days) | Blood samples will be collected to determine the AUC0-inf of MK-7962. |
| Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962 | At designated timepoints (up to 28 days postdose) | Blood samples will be collected to determine the AUC0-28 days of MK-7962. |
| Apparent Terminal Half-life (t1/2) of MK-7962 | At designated timepoints (up to 120 days) | Blood samples will be collected to determine the t1/2 of MK-7962. |
| Apparent Clearance (CL/F) of MK-7962 | At designated timepoints (up to 120 days) | Blood samples will be collected to determine the CL/F of MK-7962. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962 | At designated timepoints (up to 120 days) | Blood samples will be collected to determine the Vz/F of MK-7962. |
Countries
China
Outcome results
None listed