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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Biological: Sotatercept; Biological: Sotatercept Autoinjector

• Registration Number: NCT06930664
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-16
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Study Start: 2025-05-16
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Subcutaneous Injection	Sotatercept	Participants will receive a single subcutaneous high dose of sotatercept administered via syringe.
High Dose Subcutaneous Autoinjector	Sotatercept Autoinjector	Participants will receive a single subcutaneous high dose of sotatercept administered via autoinjector.
Low Dose Subcutaneous Autoinjector	Sotatercept Autoinjector	Participants will receive a single subcutaneous low dose of sotatercept administered via autoinjector.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose	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.
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose	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.
Maximum Observed Concentration (Cmax) of Sotatercept at High Dose	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 Outcome Measures

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