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Completed

NCT Number: NCT06821334

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital (Site 0001)

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-6194

Biological

Subcutaneous Administration

Placebo

Biological

Subcutaneous administration

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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