A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)
A Randomized, Open Label, Parallel Group Phase 1 Study to Compare Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MK-1406 as Three Injections Compared With Two Injections in Healthy Adult Participants
1 other identifier
interventional
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2026
Typical duration for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2026
CompletedFirst Posted
Study publicly available on registry
August 3, 2026
CompletedStudy Start
First participant enrolled
September 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2027
Study Completion
Last participant's last visit for all outcomes
February 5, 2027
August 3, 2026
July 1, 2026
5 months
July 29, 2026
July 29, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406
Blood samples will be collected at pre-specified timepoints to determine the AUC0-4w of MK-1406.
Predose and at designated timepoints up to 4 weeks postdose
Part 1 and Part 2: Number of Participants Who Experience One or More Adverse Events (AEs)
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.
Up to approximately 43 days postdose
Part 1 and Part 2: Number of Participants Who Experience At Least One Solicited Injection-Site Reaction
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.
Up to approximately 7 days postdose
Part 1 and Part 2: 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 43 days postdose
Secondary Outcomes (3)
Part 1: Maximum Plasma Concentration (Cmax) of MK-1406
Predose and at designated timepoints up to 4 weeks postdose
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-1406
Predose and at designated timepoints up to 4 weeks postdose
Part 1: Plasma Concentration of MK-1406 at 4 Weeks (C4w)
Predose and at designated timepoints up to 4 weeks postdose
Study Arms (2)
MK-1406 3-Injections
EXPERIMENTALParticipants receive 3 subcutaneous (SQ) injections of MK-1406 on Day 1.
MK-1406 2-Injections
EXPERIMENTALParticipants receive 2 SQ injections of MK-1406 on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- Is in good health
- Has body mass index (BMI) 18.0 to 32.0 kg/m\^2
You may not qualify if:
- History of clinically significant endocrine, Gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- History of cancer (malignancy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2026
First Posted
August 3, 2026
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
February 5, 2027
Study Completion (Estimated)
February 5, 2027
Last Updated
August 3, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf