A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Sotatercept; Other: Placebo

• Registration Number: NCT06843460
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them. The study will also measure what happens to sotatercept in a person's body over time (pharmacokinetic or PK study).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-22
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

• Is in good health
• Has a BMI≥18.0 kg/m^2 and ≤28.0 kg/m^2

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

• Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has been treated with a sotatercept or luspatercept

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sotatercept Dose Level 1	Sotatercept	Participants received a single dose of sotatercept at dose level 1.
Sotatercept Dose Level 2	Sotatercept	Participants received a single dose of sotatercept at dose level 2.
Placebo	Placebo	Participants received a single dose of placebo to sotatercept.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 120 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Due to an AE	Up to approximately 120 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Maximum Serum Concentration (Cmax) of Sotatercept	At designated timepoints (up to 120 days)	Blood samples will be collected to determine the Cmax of sotatercept.
Apparent Terminal Half-life (t1/2) of MK-7962	At designated timepoints (up to 120 days)	Blood samples will be collected to determine the t1/2 of MK-7962.
Time to Maximum Serum Concentration (Tmax) of Sotatercept	Predose and at designated timepoints up to 120 days postdose	Blood samples will be collected to determine the Tmax of sotatercept.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962	At designated timepoints (up to 120 days)	Blood samples will be collected to determine the AUC0-inf of MK-7962.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962	At designated timepoints (up to 120 days)	Blood samples will be collected to determine the AUC0-last of MK-7962.
Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962	At designated timepoints (up to 28 days postdose)	Blood samples will be collected to determine the AUC0-28 days of MK-7962.
Apparent Clearance (CL/F) of MK-7962	At designated timepoints (up to 120 days)	Blood samples will be collected to determine the CL/F of MK-7962.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962	At designated timepoints (up to 120 days)	Blood samples will be collected to determine the Vz/F of MK-7962.

Trial Locations

Locations (1)

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001); 🇨🇳 Shanghai, Shanghai, China