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

A Single-Administration Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Japanese Participants

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2051220078
Enrollment
26
Registered
2022-08-20
Start date
2022-09-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension

Interventions

Panel A: MK-7962 0.3mg/kg or placebo, Panel B: MK-7962 0.7mg/kg or placebo

Sponsors

Yoshiyuki Tanaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Adverse event, MK-7962 PK

Secondary

MeasureTime frame
Anti-drug antibody

Contacts

Public ContactMSDJRCT inquiry mailbox

MSD K.K.

msdjrct@msd.com+81-3-6272-1957

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026