Healthy
Conditions
Brief summary
The goal of this study is to learn how safe MK-6194 is in healthy Chinese adults and how well people tolerate it.
Interventions
BIOLOGICALMK-6194
Subcutaneous Administration
BIOLOGICALPlacebo
Subcutaneous administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Is in good health * Has body mass index (BMI) within 18.0 to 28.0 kg/m\^2 (inclusive) and weight ≥50 kg
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to 42 days post dose | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
| Number of Participants Who Discontinue Study Due to an AE | Up to 42 days post dose | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Serum Concentration (Cmax) of MK-6194 | Up to 42 days post dose | Blood samples will be collected at specified intervals to determine the Cmax of MK-6194. |
| Time to Maximum Serum Concentration (Tmax) of MK-6194 | Up to 42 days post dose | Blood samples will be collected at specified intervals to determine the Tmax of MK-6194. |
| Apparent Terminal Half-life (t1/2) of MK-6194 | Up to 42 days post dose | Blood samples will be collected at specified intervals to determine the t1/2 of MK-6194. |
| Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of MK-6194 | Up to 42 days post dose | Blood samples will be collected at specified intervals to determine the AUC0-last of MK-6194. |
| Apparent Volume of Distribution during terminal phase (Vz/F) of MK-6194 | Up to 42 days post dose | Blood samples will be collected at specified intervals to determine the Vz/F of MK-6194. |
| Incidence of Antidrug Antibodies (ADA) to MK-6194 | Up to 42 days post dose | Blood samples will be collected at specified intervals to determine the ADA response to MK-6194. |
| Apparent Clearance (CL/F) of MK-6194 | Up to 42 days post dose | Blood samples will be collected at specified intervals to determine the CL/F of MK-6194. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194 | Up to 42 days post dose | Blood samples will be collected at specified intervals to determine the AUC0-inf of MK-6194. |
Countries
China
Outcome results
None listed