Single Administration Study of Sotatercept (MK-7962) in Healthy Japanese Participants

JRCT ID: jRCT2051220078

Registered date:20/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pulmonary arterial hypertension
• Date of first enrollment: 14/09/2022
• Target sample size: 26
• Study type: Interventional
• Intervention(s): Panel A: MK-7962 0.3mg/kg or placebo, Panel B: MK-7962 0.7mg/kg or placebo

Outcome(s)

• Primary Outcome: Adverse event, MK-7962 PK
• Secondary Outcome: Anti-drug antibody

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

1) Be in good health based on medical history, physical examination, vital signs measurements, and 12-Lead ECGs performed before randomization.
2) Be in good health based on laboratory safety tests obtained at the screening visit and before administration of the initial dose of study intervention.
3) Must have a body weight of at least 40 kg, BMI >=18.5 and <=30 kg/m2, inclusive.

Exclude criteria

1) Have prior exposure to sotatercept or luspatercept.
2) History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
3) History of cancer (malignancy).

Related Information

• Primary Sponsor: Yoshiyuki Tanaka