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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06930664

Enrollment

146

Registered

2025-04-16

Start date

2025-05-16

Completion date

2025-11-25

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

BIOLOGICALSotatercept

Subcutaneous Injection

BIOLOGICALSotatercept Autoinjector

Subcutaneous Auto Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026