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
2 other identifiers
interventional
146
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2025
Typical duration for phase_1 healthy
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2025
CompletedFirst Posted
Study publicly available on registry
April 16, 2025
CompletedStudy Start
First participant enrolled
May 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2025
CompletedDecember 15, 2025
December 1, 2025
6 months
April 9, 2025
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose
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
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
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 Outcomes (13)
Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose
Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose
Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose
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
Predose and at designated timepoints (up to approximately 120 days postdose
Cmax of Sotatercept Low Dose
Predose and at designated timepoints (up to approximately 120 days postdose
- +8 more secondary outcomes
Study Arms (3)
High Dose Subcutaneous Injection
ACTIVE COMPARATORParticipants will receive a single subcutaneous high dose of sotatercept administered via syringe.
High Dose Subcutaneous Autoinjector
EXPERIMENTALParticipants will receive a single subcutaneous high dose of sotatercept administered via autoinjector.
Low Dose Subcutaneous Autoinjector
EXPERIMENTALParticipants will receive a single subcutaneous low dose of sotatercept administered via autoinjector.
Interventions
Subcutaneous Injection
Subcutaneous Auto Injection
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Anaheim Clinical Trials ( Site 0007)
Anaheim, California, 92801, United States
Advanced Pharma CR, LLC ( Site 0005)
Miami, Florida, 33147, United States
QPS-MRA, LLC ( Site 0004)
South Miami, Florida, 33143, United States
Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)
Springfield, Missouri, 65802, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2025
First Posted
April 16, 2025
Study Start
May 16, 2025
Primary Completion
November 11, 2025
Study Completion
November 25, 2025
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf