Skip to main content
OpenTrials
Completed

NCT Number: NCT06930664

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials ( Site 0007), Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sotatercept

Biological

Subcutaneous Injection

Other names: MK-7962, ActRIIA-IgG1Fc, ACE-011

Sotatercept Autoinjector

Biological

Subcutaneous Auto Injection

Other names: MK-7962, ActRIIA-IgGIFc, ACE-011

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.