Healthy
Conditions
Brief summary
The purpose of this trial is to compare what happens to MK-1406 in the body of healthy participants when it is given as 2-injections and 3-injections. Researchers also want to learn about the safety of MK-1406 and if people tolerate it.
Interventions
DRUGMK-1406
Subcutaneous administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Is in good health * Has body mass index (BMI) 18.0 to 32.0 kg/m\^2
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406 | Predose and at designated timepoints up to 4 weeks postdose | Blood samples will be collected at pre-specified timepoints to determine the AUC0-4w of MK-1406. |
| Part 1 and Part 2: Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 43 days postdose | 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. |
| Part 1 and Part 2: Number of Participants Who Experience At Least One Solicited Injection-Site Reaction | Up to approximately 7 days postdose | Solicited injection-site reactions include tenderness, pain, redness/erythema, and swelling. Participants will record injection site reactions using a paper diary. The number of participants with solicited injection-site reactions will be reported. |
| Part 1 and Part 2: Number of Participants Who Discontinue Study Due to an AE | Up to approximately 43 days postdose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Maximum Plasma Concentration (Cmax) of MK-1406 | Predose and at designated timepoints up to 4 weeks postdose | Blood samples will be collected at pre-specified timepoints to determine the Cmax of MK-1406. |
| Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-1406 | Predose and at designated timepoints up to 4 weeks postdose | Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-1406. |
| Part 1: Plasma Concentration of MK-1406 at 4 Weeks (C4w) | Predose and at designated timepoints up to 4 weeks postdose | Blood samples will be collected at pre-specified timepoints to determine the C4w of MK-1406. |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed