A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)

December 11, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation

The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

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

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials ( Site 0007)
    • Florida
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC ( Site 0005)
      • South Miami, Florida, United States, 33143
        • QPS-MRA, LLC ( Site 0004)
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

  • Is in good health before randomization
  • Has a body weight between 75 and 100 kg, inclusive

  • Is assigned female sex at birth and is a participant of nonchildbearing potential (PONCBP) defined as one of the following:

    • Premenarchal
    • Premenopausal with documented hysterectomy and/or bilateral salpingectomy
    • Postmenopausal
    • Medical cause of permanent infertility (eg, Müllerian agenesis, androgen insensitivity)

Exclusion Criteria:

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

  • Has a history of opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia)
  • Has had a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within 3 months prior to screening

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Dose Subcutaneous Injection
Participants will receive a single subcutaneous high dose of sotatercept administered via syringe.
Biological: Sotatercept
Subcutaneous Injection
Other Names:
  • ACE-011
  • MK-7962
  • ActRIIA-IgG1Fc
Experimental: High Dose Subcutaneous Autoinjector
Participants will receive a single subcutaneous high dose of sotatercept administered via autoinjector.
Biological: Sotatercept Autoinjector
Subcutaneous Auto Injection
Other Names:
  • ACE-011
  • MK-7962
  • ActRIIA-IgGIFc
Experimental: Low Dose Subcutaneous Autoinjector
Participants will receive a single subcutaneous low dose of sotatercept administered via autoinjector.
Biological: Sotatercept Autoinjector
Subcutaneous Auto Injection
Other Names:
  • ACE-011
  • MK-7962
  • ActRIIA-IgGIFc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose)
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose)
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Maximum Observed Concentration (Cmax) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Tmax of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the t1/2 of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the CL/F of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Vz/F of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Cmax of Sotatercept Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Tmax of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Tmax of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
AUC0-inf of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
AUC0-last of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
t1/2 of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the t1/2 of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
CL/F of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the CL/F of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Vz/F of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Vz/F of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Number of Participants who Experienced 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 the study intervention, whether or not considered related to the study intervention.
Up to approximately 120 days
Number of Participants who Discontinued the 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 the study intervention, whether or not considered related to the study intervention.
Up to approximately 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)

May 16, 2025

Primary Completion (Actual)

November 11, 2025

Study Completion (Actual)

November 25, 2025

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7962-027
  • MK-7962-027 (Other Identifier: MSD)

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

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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