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

NCT06821334 | Completed Phase 1 FDA Drug

• 2 other identifiers: 6194-014MK-6194-014
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  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

  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 Outcomes (8)

• Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (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

  Up to 42 days post dose

• Maximum Serum Concentration (Cmax) of MK-6194

  Up to 42 days post dose

• Time to Maximum Serum Concentration (Tmax) of MK-6194

  Up to 42 days post dose

• Apparent Terminal Half-life (t1/2) of MK-6194

  Up to 42 days post dose

Study Arms (3)

Panel A

EXPERIMENTAL

Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo.

Biological: MK-6194; Biological: Placebo

Panel B

EXPERIMENTAL

Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo.

Biological: MK-6194; Biological: Placebo

Panel C

EXPERIMENTAL

Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo.

Biological: MK-6194; Biological: Placebo

Interventions

MK-6194 BIOLOGICAL

Subcutaneous Administration

Panel A; Panel B; Panel C

Placebo BIOLOGICAL

Subcutaneous administration

Panel A; Panel B; Panel C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Peking University Third Hospital (Site 0001)

Beijing, Beijing Municipality, 100191, China

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 12, 2025
• Study Start: April 23, 2024
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)