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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: MK-6194; Biological: Placebo

• Registration Number: NCT06821334
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-23
• Primary Completion: 2024-08-09
• Study Completion: 2024-08-09
• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Panel A	Placebo	Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo.
Panel B	Placebo	Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo.
Panel A	MK-6194	Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 1) or Placebo.
Panel C	MK-6194	Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo.
Panel C	Placebo	Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 3) or Placebo.
Panel B	MK-6194	Participants receive single dose subcutaneous (SC) injection of MK-6194 (Dose 2) or Placebo.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	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.
Number of Participants Who Discontinue Study Due to an AE	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 Outcome Measures

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

Trial Locations

Locations (1)

Peking University Third Hospital (Site 0001); 🇨🇳 Beijing, Beijing, China