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Not yet recruiting NCT07743151

A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MK-1406.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug MK-1406
    Subcutaneous administration

Primary outcome measures

  • 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]
  • Part 1 and Part 2: Number of Participants Who Experience One or More Adverse Events (AEs) [Time frame: Up to approximately 43 days postdose]
  • 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]
  • Part 1 and Part 2: Number of Participants Who Discontinue Study Due to an AE [Time frame: Up to approximately 43 days postdose]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07743151 · 1406-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗