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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Biological: Sotatercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT06843460

7962-021

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

Sotatercept Dose Level 1

Experimental group

Description:

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

Treatment:

Biological: Sotatercept

Sotatercept Dose Level 2

Experimental group

Description:

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

Treatment:

Biological: Sotatercept

Placebo

Placebo Comparator group

Description:

Participants received a single dose of placebo to sotatercept.

Treatment:

Other: Placebo