Clinical trial NCT06843460: A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)
Official title: A Single-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Chinese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 120 days
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 120 days
measure: Maximum Serum Concentration (Cmax) of Sotatercept
timeFrame: At designated timepoints (up to 120 days)
measure: Time to Maximum Serum Concentration (Tmax) of Sotatercept
timeFrame: Predose and at designated timepoints up to 120 days postdose
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962
timeFrame: At designated timepoints (up to 120 days)
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962
timeFrame: At designated timepoints (up to 120 days)
measure: Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962
timeFrame: At designated timepoints (up to 28 days postdose)
measure: Apparent Terminal Half-life (t1/2) of MK-7962
timeFrame: At designated timepoints (up to 120 days)
measure: Apparent Clearance (CL/F) of MK-7962
timeFrame: At designated timepoints (up to 120 days)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962
timeFrame: At designated timepoints (up to 120 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
state: Shanghai
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: