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

Merck Sharp & Dohme (MSD)

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: Sotatercept; Biological: Sotatercept Autoinjector

Study type: Interventional

Funder types: Industry

Identifiers

NCT06930664

7962-027

MK-7962-027 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 3 patient groups

High Dose Subcutaneous Injection

Active Comparator group

Description:

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

Treatment:

Biological: Sotatercept

High Dose Subcutaneous Autoinjector

Experimental group

Description:

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

Treatment:

Biological: Sotatercept Autoinjector

Low Dose Subcutaneous Autoinjector

Experimental group

Description:

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

Treatment:

Biological: Sotatercept Autoinjector