Status:
COMPLETED
A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Healthy
Eligibility:
FEMALE
18-85 years
Phase:
PHASE1
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 pers...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2025
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06930664
Start Date
May 16 2025
End Date
November 25 2025
Last Update
December 15 2025
Active Locations (4)
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1
Anaheim Clinical Trials ( Site 0007)
Anaheim, California, United States, 92801
2
Advanced Pharma CR, LLC ( Site 0005)
Miami, Florida, United States, 33147
3
QPS-MRA, LLC ( Site 0004)
South Miami, Florida, United States, 33143
4
Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)
Springfield, Missouri, United States, 65802