HealthyPhase 1NCT07743151
A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)
A Phase 1 study testing MK-1406 in people with Healthy, run by Merck Sharp & Dohme LLC at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-1406
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Sep 2026to 5 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Parexel Baltimore EPCU ( Site 0010)
Baltimore, Maryland, 21225
Study Coordinator, 667-210-5300
- Recruiting
Velocity Clinical Research, Cleveland ( Site 0005)
Cleveland, Ohio, 44122
Study Coordinator, 216-682-0320
- Recruiting
Research Centers of America ( Hollywood ) ( Site 0008)
Hollywood, Florida, 33024
Study Coordinator, 954-990-7649
- Recruiting
Hassman Research Institute Marlton Site ( Site 0001)
Marlton, New Jersey, 08053
Study Coordinator, 856-452-9901
- Recruiting
ICON Early Phase Services ( Site 0004)
San Antonio, Texas, 78232
Study Coordinator, 210-225-5437
- Recruiting
QPS-MRA, LLC ( Site 0007)
South Miami, Florida, 33143
Study Coordinator, 305-722-0970
- Recruiting
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)
Springfield, Missouri, 65802
Study Coordinator, 417-831-2048
About this study
Official title: 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
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.
- Conditions
- Healthy
- Being tested
- MK-1406
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1406Drug
Subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| MK-1406 3-Injections | Experimental | Participants receive 3 subcutaneous (SQ) injections of MK-1406 on Day 1. Receives: Drug: MK-1406 |
| MK-1406 2-Injections | Experimental | Participants receive 2 SQ injections of MK-1406 on Day 1. Receives: Drug: MK-1406 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 43 days postdose
Secondary outcomes (3)
Part 1: Maximum Plasma Concentration (Cmax) of MK-1406
Blood samples will be collected at pre-specified timepoints to determine the Cmax of MK-1406.
Measured: Predose and at designated timepoints up to 4 weeks postdose
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-1406
Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-1406.
Measured: Predose and at designated timepoints up to 4 weeks postdose
Part 1: Plasma Concentration of MK-1406 at 4 Weeks (C4w)
Blood samples will be collected at pre-specified timepoints to determine the C4w of MK-1406.
Measured: Predose and at designated timepoints up to 4 weeks postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start10 Sep 2026
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743151
- Sponsor's protocol ID
- 1406-008
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07743151
- Acronym / sponsor ID
- 1406-008
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-1406 3-Injections | Experimental | Drug: MK-1406Participants receive 3 subcutaneous (SQ) injections of MK-1406 on Day 1. |
| MK-1406 2-Injections | Experimental | Drug: MK-1406Participants receive 2 SQ injections of MK-1406 on Day 1. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Has body mass index (BMI) 18.0 to 32.0 kg/m^2
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-1406Subcutaneous administration | Drug | MK-1406 2-Injections, MK-1406 3-Injections |
Primary outcome
Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Part 1: Maximum Plasma Concentration (Cmax) of MK-1406
Time frame: Predose and at designated timepoints up to 4 weeks postdose
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-1406
Time frame: Predose and at designated timepoints up to 4 weeks postdose
Part 1: Plasma Concentration of MK-1406 at 4 Weeks (C4w)
Time frame: Predose and at designated timepoints up to 4 weeks postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-1406 in people with Healthy, run by Merck Sharp & Dohme LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406 (time frame: Predose and at designated timepoints up to 4 weeks postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.