Sotatercept Formulations in Healthy Individuals

Recruiting at 3 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Opportunistic infection, Serious infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

146 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy females who weigh between 75 and 100 kg. They must be either premenarchal, premenopausal with a hysterectomy/salpingectomy, have a medical cause of permanent infertility, or be postmenopausal.

Inclusion Criteria

I am postmenopausal.

I am premenopausal and have had a hysterectomy or both ovaries removed.

I have a medical condition that causes permanent infertility.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of sotatercept, either high or low, administered via syringe or autoinjector

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics and safety, with blood samples collected at designated timepoints

Up to approximately 120 days

Treatment Details

Interventions

• Sotatercept

Trial Overview The study compares two forms of the drug Sotatercept: one as a liquid in an autoinjector and the other as a lyophilized (freeze-dried) formulation to see how they are processed by the body over time.

Participant Groups

Group I: Low Dose Subcutaneous Autoinjector Experimental Treatment 2 Interventions

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

Group II: High Dose Subcutaneous Autoinjector Experimental Treatment 2 Interventions

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

Group III: High Dose Subcutaneous Injection Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University