A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)

NCT06843460 | Completed Phase 1 FDA Drug

• 1 other identifier: 7962-021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them. The study will also measure what happens to sotatercept in a person's body over time (pharmacokinetic or PK study).

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

• Number of Participants Who Experience an Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  Up to approximately 120 days

• Number of Participants Who Discontinue Study Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.

  Up to approximately 120 days

• Maximum Serum Concentration (Cmax) of Sotatercept

  Blood samples will be collected to determine the Cmax of sotatercept.

  At designated timepoints (up to 120 days)

• Time to Maximum Serum Concentration (Tmax) of Sotatercept

  Blood samples will be collected to determine the Tmax of sotatercept.

  Predose and at designated timepoints up to 120 days postdose

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962

  Blood samples will be collected to determine the AUC0-last of MK-7962.

  At designated timepoints (up to 120 days)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962

  Blood samples will be collected to determine the AUC0-inf of MK-7962.

  At designated timepoints (up to 120 days)

• Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962

  Blood samples will be collected to determine the AUC0-28 days of MK-7962.

  At designated timepoints (up to 28 days postdose)

• Apparent Terminal Half-life (t1/2) of MK-7962

  Blood samples will be collected to determine the t1/2 of MK-7962.

  At designated timepoints (up to 120 days)

• Apparent Clearance (CL/F) of MK-7962

  Blood samples will be collected to determine the CL/F of MK-7962.

  At designated timepoints (up to 120 days)

• Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962

  Blood samples will be collected to determine the Vz/F of MK-7962.

  At designated timepoints (up to 120 days)

Study Arms (3)

Sotatercept Dose Level 1

EXPERIMENTAL

Participants received a single dose of sotatercept at dose level 1.

Biological: Sotatercept

Sotatercept Dose Level 2

EXPERIMENTAL

Participants received a single dose of sotatercept at dose level 2.

Biological: Sotatercept

Placebo

PLACEBO COMPARATOR

Participants received a single dose of placebo to sotatercept.

Other: Placebo

Interventions

Sotatercept BIOLOGICAL

Single subcutaneous injection

Also known as: MK-7962, ActRIIA-IgG1Fc, ACE-011

Sotatercept Dose Level 1; Sotatercept Dose Level 2

Placebo OTHER

Single subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health
• Has a BMI≥18.0 kg/m\^2 and ≤28.0 kg/m\^2

You may not qualify if:

• Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has been treated with a sotatercept or luspatercept

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)

Shanghai, Shanghai Municipality, 200032, China

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

ACE-011

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The first 12 participants were randomized 1:3 between placebo or 0.3 mg/kg of sotatercept. After those 12 participants were complete, the next 12 were randomized 1:3 between placebo or 0.7 mg/kg of sotatercept.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: November 22, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)