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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2024-05-21

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sotatercept Dose Level 1

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

Group Type EXPERIMENTAL

Sotatercept

Intervention Type BIOLOGICAL

Single subcutaneous injection

Sotatercept Dose Level 2

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

Group Type EXPERIMENTAL

Sotatercept

Intervention Type BIOLOGICAL

Single subcutaneous injection

Placebo

Participants received a single dose of placebo to sotatercept.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single subcutaneous injection

Interventions

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Sotatercept

Single subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Single subcutaneous injection

Intervention Type OTHER

Other Intervention Names

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MK-7962 ActRIIA-IgG1Fc ACE-011

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes