Systemic Sclerosis
Conditions
Brief summary
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.
Interventions
DRUGMK-2225
Subcutaneous administration
OTHERPlacebo
Subcutaneous administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded
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 before randomization * Body Mass Index (BMI) ≤32 kg/m\^2, inclusive
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 20 weeks | 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 Treatment Due to an AE | Up to approximately 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) of MK-2225 | At designated timepoints (up to approximately 16 weeks) | Blood samples will be collected to determine the Tmax of MK-2225. |
| Area Under the Concentration-Time Curve from Time 0 to Tau (AUC0-τ) of MK-2225 | At designated timepoints (up to 16 approximately weeks) | Blood samples will be collected to determine the AUC0-τ of MK-2225. |
| Maximum Plasma Concentration (Cmax) of MK-2225 | At designated timepoints (up to approximately 16 weeks) | Blood samples will be collected to determine the Cmax of MK-2225. |
| Mean Accumulation Ratio of MK-2225 | At designated timepoints (up to approximately 16 weeks) | Blood samples will be collected at designated timepoints to determine the mean accumulation ratio of MK-2225. |
| Apparent Terminal Half-life (t1/2) of MK-2225 | At designated timepoints (up to approximately 16 weeks) | Blood samples will be collected to determine the t1/2 of MK-2225. |
| Lowest Plasma Concentration (Ctrough) of MK-2225 | At designated timepoints (up to approximately 16 weeks) | Blood samples will be collected to determine the Ctrough of MK-2225. |
Countries
United States
Outcome results
None listed