Single Administration Study of Sotatercept (MK-7962) in Healthy Japanese Participants
Phase 1
- Conditions
- Pulmonary arterial hypertension
- Registration Number
- JPRN-jRCT2051220078
- Lead Sponsor
- Yoshiyuki Tanaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 26
Inclusion 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.
Exclusion 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event, MK-7962 PK
- Secondary Outcome Measures
Name Time Method Anti-drug antibody