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

Description

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.

Conditions

Healthy

Study Overview

Study Details

Study overview

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.

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

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

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Anaheim

Anaheim Clinical Trials ( Site 0007), Anaheim, California, United States, 92801

Miami

Advanced Pharma CR, LLC ( Site 0005), Miami, Florida, United States, 33147

South Miami

QPS-MRA, LLC ( Site 0004), South Miami, Florida, United States, 33143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2026-01-30