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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2025-11-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High Dose Subcutaneous Injection

Participants will receive a single subcutaneous high dose of sotatercept administered via syringe.

Group Type ACTIVE_COMPARATOR

Sotatercept

Intervention Type BIOLOGICAL

Subcutaneous Injection

High Dose Subcutaneous Autoinjector

Participants will receive a single subcutaneous high dose of sotatercept administered via autoinjector.

Group Type EXPERIMENTAL

Sotatercept Autoinjector

Intervention Type BIOLOGICAL

Subcutaneous Auto Injection

Low Dose Subcutaneous Autoinjector

Participants will receive a single subcutaneous low dose of sotatercept administered via autoinjector.

Group Type EXPERIMENTAL

Sotatercept Autoinjector

Intervention Type BIOLOGICAL

Subcutaneous Auto Injection

Interventions

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Sotatercept

Subcutaneous Injection

Intervention Type BIOLOGICAL

Sotatercept Autoinjector

Subcutaneous Auto Injection

Intervention Type BIOLOGICAL

Other Intervention Names

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MK-7962 ActRIIA-IgG1Fc ACE-011 MK-7962 ActRIIA-IgGIFc ACE-011

Eligibility Criteria

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Inclusion 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes