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Completed

NCT Number: NCT06843460

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

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).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

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

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • 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

Treatment and study plan

Sotatercept

Biological

Single subcutaneous injection

Other names: MK-7962, ActRIIA-IgG1Fc, ACE-011

Placebo

Other

Single subcutaneous injection

Primary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 120 days

    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.

  2. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 120 days

    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.

  3. Maximum Serum Concentration (Cmax) of Sotatercept

    Time frame: At designated timepoints (up to 120 days)

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

  4. Time to Maximum Serum Concentration (Tmax) of Sotatercept

    Time frame: Predose and at designated timepoints up to 120 days postdose

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

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

    Time frame: At designated timepoints (up to 120 days)

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

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

    Time frame: At designated timepoints (up to 120 days)

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

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

    Time frame: At designated timepoints (up to 28 days postdose)

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

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

    Time frame: At designated timepoints (up to 120 days)

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

  9. Apparent Clearance (CL/F) of MK-7962

    Time frame: At designated timepoints (up to 120 days)

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

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

    Time frame: At designated timepoints (up to 120 days)

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Chinese Participants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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