A Single Dose Study of MK-6194 in Healthy Chinese Participants (MK-6194-014)

February 10, 2025 updated by: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Placebo-Controlled Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics of MK-6194 in Healthy Chinese Participants

The goal of this study is to learn how safe MK-6194 is in healthy Chinese adults and how well people tolerate it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

  • Is in good health
  • Has body mass index (BMI) within 18.0 to 28.0 kg/m^2 (inclusive) and weight ≥50 kg

Exclusion Criteria:

The key 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
  • Has a history of opportunistic infection, Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panel A
Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo.
Biological: MK-6194
Subcutaneous Administration
Biological: Placebo
Subcutaneous administration
Experimental: Panel B
Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo.
Biological: MK-6194
Subcutaneous Administration
Biological: Placebo
Subcutaneous administration
Experimental: Panel C
Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo.
Biological: MK-6194
Subcutaneous Administration
Biological: Placebo
Subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to 42 days post dose
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 42 days post dose
Number of Participants Who Discontinue Study Due to an AE
Time Frame: Up to 42 days post dose
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 42 days post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of MK-6194
Time Frame: Up to 42 days post dose
Blood samples will be collected at specified intervals to determine the AUC0-last of MK-6194.
Up to 42 days post dose
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194
Time Frame: Up to 42 days post dose
Blood samples will be collected at specified intervals to determine the AUC0-inf of MK-6194.
Up to 42 days post dose
Maximum Serum Concentration (Cmax) of MK-6194
Time Frame: Up to 42 days post dose
Blood samples will be collected at specified intervals to determine the Cmax of MK-6194.
Up to 42 days post dose
Time to Maximum Serum Concentration (Tmax) of MK-6194
Time Frame: Up to 42 days post dose
Blood samples will be collected at specified intervals to determine the Tmax of MK-6194.
Up to 42 days post dose
Apparent Terminal Half-life (t1/2) of MK-6194
Time Frame: Up to 42 days post dose
Blood samples will be collected at specified intervals to determine the t1/2 of MK-6194.
Up to 42 days post dose
Apparent Clearance (CL/F) of MK-6194
Time Frame: Up to 42 days post dose
Blood samples will be collected at specified intervals to determine the CL/F of MK-6194.
Up to 42 days post dose
Apparent Volume of Distribution during terminal phase (Vz/F) of MK-6194
Time Frame: Up to 42 days post dose
Blood samples will be collected at specified intervals to determine the Vz/F of MK-6194.
Up to 42 days post dose
Incidence of Antidrug Antibodies (ADA) to MK-6194
Time Frame: Up to 42 days post dose
Blood samples will be collected at specified intervals to determine the ADA response to MK-6194.
Up to 42 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2024

Primary Completion (Actual)

August 9, 2024

Study Completion (Actual)

August 9, 2024

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 6194-014
  • MK-6194-014 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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