Japanese subjects with elevated Lp(a)
Conditions
Interventions
A single dose of up to 4 different doses across up to 4 cohorts
Sponsors
Fok Henry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Males or nonpregnant, nonlactating females who are 20 to 70 years of age. - Body mass index at least 18 kg/m2 but no more than 32 kg/m2 - Elevated Lp(a) in the blood - Agrees to use effective contraception, if applicable
Exclusion criteria
Exclusion criteria: - Patients have a history of established cardiovascular disease. - Patients with a history of cancer - Patients with moderate or serious liver conditions - Patients with serious mental illness or psychiatric disorder - Positive for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) - History or clinical evidence of alcohol misuse and/or illegal drug use within the 6 months before Screening - History of multiple drug allergies - History of intolerance to subcutaneous injections (hypersensitivity etc.) or scarring in skin areas where subcutaneous doses may need to be administered. - Type 1 diabetes mellitus or poorly controlled (glycated haemoglobin 10% and over or 86 mmol/mol and over) type 2 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The PK parameters of zerlasiran following single subcutaneous administration of up to 4 different doses | — |
Contacts
Public ContactRitsuko Cardona
Medpace Japan K.K.
Outcome results
None listed