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

February 20, 2025 updated by: Merck Sharp & Dohme LLC

A Single-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Chinese Participants

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (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 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 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sotatercept Dose Level 1
Participants received a single dose of sotatercept at dose level 1.
Biological: Sotatercept
Single subcutaneous injection
Other Names:
  • ACE-011
  • MK-7962
  • ActRIIA-IgG1Fc
Experimental: Sotatercept Dose Level 2
Participants received a single dose of sotatercept at dose level 2.
Biological: Sotatercept
Single subcutaneous injection
Other Names:
  • ACE-011
  • MK-7962
  • ActRIIA-IgG1Fc
Placebo Comparator: Placebo
Participants received a single dose of placebo to sotatercept.
Other: Placebo
Single subcutaneous injection

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 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.
Up to approximately 120 days
Number of Participants Who Discontinue Study Due to an AE
Time Frame: 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.
Up to approximately 120 days
Maximum Serum Concentration (Cmax) of Sotatercept
Time Frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the Cmax of sotatercept.
At designated timepoints (up to 120 days)
Time to Maximum Serum Concentration (Tmax) of Sotatercept
Time Frame: Predose and at designated timepoints up to 120 days postdose
Blood samples will be collected to determine the Tmax of sotatercept.
Predose and at designated timepoints up to 120 days postdose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962
Time Frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the AUC0-last of MK-7962.
At designated timepoints (up to 120 days)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962
Time Frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the AUC0-inf of MK-7962.
At designated timepoints (up to 120 days)
Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962
Time Frame: At designated timepoints (up to 28 days postdose)
Blood samples will be collected to determine the AUC0-28 days of MK-7962.
At designated timepoints (up to 28 days postdose)
Apparent Terminal Half-life (t1/2) of MK-7962
Time Frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the t1/2 of MK-7962.
At designated timepoints (up to 120 days)
Apparent Clearance (CL/F) of MK-7962
Time Frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the CL/F of MK-7962.
At designated timepoints (up to 120 days)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962
Time Frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the Vz/F of MK-7962.
At designated timepoints (up to 120 days)

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)

November 22, 2023

Primary Completion (Actual)

May 21, 2024

Study Completion (Actual)

May 21, 2024

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 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 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 7962-021

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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