A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT06930664
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 146
- Starts
- 2025-05-16
- Expected to finish
- 2025-11-25
- Last updated by the study team
- 2025-12-15
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Anaheim Clinical Trials ( Site 0007) — Anaheim, California, United States
- Advanced Pharma CR, LLC ( Site 0005) — Miami, Florida, United States
- QPS-MRA, LLC ( Site 0004) — South Miami, Florida, United States
- Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003) — Springfield, Missouri, United States
Full record on ClinicalTrials.gov
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